Medical Compliance Auditor Stellenangebote

Job vor 4 Tagen bei Jobleads gefunden

Vivalyx GmbH: Head of Quality/ QMR

• Köln, Nordrhein- Westfalen Führungs-/ Leitungspositionen At Vivalyx, a medical technology startup based in Aachen, were on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to dramatically improve the vitality and availability of donor organs. As we gear up for certification and related studies, were seeking dedicated team members (m/f/d) to join us starting as soon as possible, for 32-40 hours per week. Tasks As the Head of Quality and QMR, you will be responsible for maintaining and continuously improving our Quality Management System (QMS) in alignment with ISO 13485 and FDA 21 CFR Part 820 standards. You will play a critical role in ensuring the quality of our medical devices from design and development through to supplier quality management, manufacturing oversight, and risk management. Key responsibilities: Quality Management System (QMS) : Develop, implement, and maintain the QMS in compliance with ISO 13485, covering the scope of design, development, and manufacturing of medical devices. Compliance Auditing: Conduct internal and supplier audits to ensure compliance with MDR, ISO 13485, FDA 21 CFR Part 820, and other relevant standards. Prepare the organization for external audits. Supplier Quality Management: Lead supplier quality audits, ensuring that all suppliers meet the necessary quality and regulatory requirements. Manufacturing Oversight: Ensure manufacturing processes align with quality standards, conducting regular quality checks and overseeing adherence to production protocols. Development Quality: Collaborate closely with the product development team to ensure that quality is embedded in every stage of the design and development process. Regulatory Quality: support the development and regulatory affairs team in risk management in accordance with ISO [...] to influence and drive quality initiatives across the organization. Flexibility to adapt to changing environments and requirements. Preferred Qualifications Experience in a medical devices startup environment. Familiarity with supplier quality management and audit processes. Experience as internal and or/ supplier auditor Experience in risk management, particularly with ISO 14971. Experience in regulatory affairs for medical devices. Benefits We provide the opportunity to work on groundbreaking technology that has a meaningful impact. Youll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program. We look forward to hearing from you by April 25th 2025. #J-18808-Ljbffr 43348872 [...]
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Job vor 4 Tagen bei Jobleads gefunden Senior Supplier Quality Engineer • Zürich Thoratec Switzerland GmbH is part of the medical device division of Abbott Laboratories, a fortune 500 company with over 115000 employees worldwide. We are the global market leader [...] performance standards. Ensure Supplier Quality Agreements are established. Conduct initial assessments and supplier audits to ensure suppliers can deliver high-quality products and materials in accordance to medical device requirements. Supplier Audits and Assessments: Conduct supplier audits and assessments to ensure compliance with quality standards. Supplier Maintenance: Maintain and manage the approved supplier list. Conduct regular reviews and re-qualifications of existing suppliers [...] a similar role. Strong knowledge of quality assurance principles, methodologies, and tools. Experience with supplier audits and assessments. Strong communication and interpersonal skills. Ability to work independently and as part of a team. Certification as ISO 9001 and/or ISO 13485 Auditor (or comparable qualification) . Certification in quality management (e. g. Six Sigma) is a plus. Working at Abbott At Abbott, [...]

Job vor 4 Tagen bei Jobleads gefunden

QEHS Superintendent

• Kaiserslautern, Rheinland- Pfalz Purpose and Scope : The QEHS Superintendent is responsible for assisting the Program QEHS Manager in the development and implementation of the Program Quality Management[...]

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[...] Boards at Site and PSO Level and ensures they are posted, accurate, and updated Coordinates the QEHS Staff and its Auditors/ inspectors to ensure successful and effective completion of required audits IAW Internal Audit procedure and industry standards. Ensures site compliance with Document Control system. Disseminates information and quality documentation to and from all sites, including Contractor Officer Representative (COR) out-briefs [...] School diploma or equivalent required. Bachelor of Science degree preferred. Experience in implementing/ managing EHS Program within the past 5 years is preferred Experience in implementing/ managing QMS Program within the past 5 years is preferred Must successfully pass Lead Auditor course if not already achieved prior to hire. Must have five years experience in quality assurance and quality control fields [...] Amentum is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veterans status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of [...]

Job vor 4 Tagen bei Jobleads gefunden Product Quality Lead • Zug Führungs-/ Leitungspositionen SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6, [...] complaints, change controls, deviations, CAPA, internal audits, product quality reviews, data training, local product release, and oversight of GDP and GMP requirements for local manufacturing, warehousing and distribution. Main Responsibilities Lead Quality Operations activities at a new manufacturing site Lead compliance assurance and monitoring of manufacturing related activities on site Lead product and processes quality data analysis and trends, identifies improvement [...] quality, efficiency, and effectiveness Minimum 10+ years of experience in Medical Device or Pharma industry in Quality disciplines Expert knowledge in medical devices/ combination products compliance (ISO 13485, QSR, MDR) Expert knowledge in statistics (Trends, simulations, capabilities analysis) Certified Internal Auditor CQE certification, Black Belt in Lean Manufacturing is a plus Demonstrated problem solving and critical thinking Clear/ logical thinking with [...]

Job vor 10 Tagen bei Jobleads gefunden

Senior Manager (f/m/d) Cybersecurity

• Erlangen, Bayern [...] quality department to support our business areas, business lines, business horizontals and technology units as well as country organizations in the development, analysis and application-oriented interpretation of international and national standards, as well as relevant laws and guidelines regarding in-vivo medical devices and in-vitro diagnostic products. Choose the best place for your work Within the scope of this position, it is [...] standards, including the ISO 270xx series, NIST and ideally the IEC 60601 series. You have participated in working groups of associations and standards bodies, ideally leading activities including meetings with policy makers. Ideally you will be a certified ISO 27001 auditor. Your attributes and skills : You can analyze complex issues and translate the needs of different stakeholders into effective compliance solutions. Your working style is purposeful, you are engaging and able to professionally lead teams with diverse cultures and personalities. [...]
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Job vor 10 Tagen bei Jobleads gefunden Director Equity Rewards Employment Tax (d/f/m) • Basel, Basel- Stadt Führungs-/ Leitungspositionen [...] path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape The Director Equity Rewards Employment Tax is responsible for overseeing all global Sandoz equity programs activities, including equity plan lifecycle management, governance, compliance, vendor management, process improvements and simplifications, implementation of new equity plans, policies, practices and procedures, and leading equity rewards projects. [...] be included in the remuneration report, say-on-pay, the note to the financial statements, and other corporate reports. Develop communication materials for plan participants and internal customers. Perform internal controls and act as the equity point of contact for the external auditor. Coordinate the implementation of new requirements and other enhancements, ensuring data integrity in collaboration with different stakeholders (e. g. , [...] are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and accommodation: Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to [...]

Job vor 10 Tagen bei Jobleads gefunden

Director Equity Rewards Employment Tax (d/f/m)

• Basel, Basel- Stadt Führungs-/ Leitungspositionen Job Description Summary See job description Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider[...]

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[...] path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape The Director Equity Rewards Employment Tax is responsible to oversee all global Sandoz equity programs activities, including equity plan lifecycle management, governance, compliance, vendor management, process improvements and simplifications, implementation of new equity plans, policies, practices and procedures, leading equity rewards projects, etc. [...] set out in the remuneration report, say-on-pay, the note to the financial statements, and other corporate reports. Develop communication materials for plan participants and internal customers. Perform internal controls and act as the equity point of contact for the external auditor. Coordinate the implementation of new requirements and other enhancements, ensure data integrity in collaboration with different stakeholders (e. g. , [...] are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and accommodation Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to [...]

Job am 30.03.2025 bei Jobleads gefunden Senior Manager Sterility/ Microbiology • Kiel, Schleswig- Holstein [...] related quality metrics are met. Manage the Sterility Assurance teams for all assigned sites to continuously comply with all quality and regulatory standard requirements. Assist during the implementation of quality and regulatory requirements (FDA, EU, GLP, and guidelines) and ensure compliance with testing SOP and specifications. Monitor the testing techniques and accuracy of all records and documentation that are done in [...] and develop direct report subordinates. Be responsible for inter-departmental compliance with company policies and corrective actions for all assigned sites. Qualifications, Knowledge, Skills: Bachelors degree in science, Microbiology, or biological science preferred. 10+ years of experience in microbiology lab in medical device or pharmaceutical. ISO Lead Auditor training, desirable. Certified Quality Engineer (ASQ) , desirable. #J-18808-Ljbffr 41215087 [...]
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Job am 30.03.2025 bei Jobleads gefunden

Process Safety Engineer (m/w/d)

• Hürth, Nordrhein- Westfalen At Vivalyx, a medical technology startup based in Aachen, were on a mission to save the lives of those suffering from organ failure. Our [...] play a critical role in ensuring the quality of our medical devices from design and development through to supplier quality management, manufacturing oversight, and risk management. Key responsibilities: Quality Management System (QMS) : Develop, implement, and maintain the QMS in compliance with ISO 13485, covering the scope of design, development, and manufacturing of medical devices. Compliance Auditing: Conduct internal and supplier [...] to influence and drive quality initiatives across the organization. Flexibility to adapt to changing environments and requirements. Preferred Qualifications: Experience in a medical devices startup environment. Familiarity with supplier quality management and audit processes. Experience as an internal and/or supplier auditor. Experience in risk management, particularly with ISO 14971. Experience in regulatory affairs for medical devices. We provide the opportunity to [...]
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Job am 02.03.2025 bei Jobleads gefunden Financial Risk Auditor, Officer, Hybrid (m/f/d) • München, Bayern Who we are looking for State Street Bank International GmbH (SSBI) is looking for a Financial Risk Auditor, Officer for the support of our Corporate[...]

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Who we are looking for State Street Bank International GmbH (SSBI) is looking for a Financial Risk Auditor, Officer for the support of our Corporate Audit Department with focus on audit engagements on Internal Capital Adequacy Assessment Process [...] requirements, support recommendations for internal control improvements and preparation of audit reports providing clear messages on key risks and key audit issues. Perform independent and objective assessments of risks and controls to improve risk management practices and assess controls for compliance with laws, regulations, company policies and business needs. Prepare or review documentation of audit work in adherence with the divisions [...] analytics, investment research trading and investment management to institutional clients. Work, Live and Grow. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance and savings plans, among other perks. Youll have access to flexible Work Programs to help you match your [...]
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Job am 25.02.2025 bei Jobleads gefunden

Compliance Solutions Manager (Copenhagen, Denmark or Hamburg, Germany)

• Hamburg, Berlin Compliance Solutions Manager (Copenhagen, Denmark or Hamburg, Germany) About the job Are you a subject matter expert when it comes to financial and tax compliance?[...]

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Compliance Solutions Manager (Copenhagen, Denmark or Hamburg, Germany) About the job Are you a subject matter expert when it comes to [...] partner on developing relevant content. Work cross-functionally with Sales, Marketing, Onboarding, and Customer Success to achieve team and company goals. Your essential skills and experience Minimum 5 years of experience, with at least 3 years as an internal or external Auditor. Consultant level or above at a leading accounting firm. Ability to develop and maintain customer-first relationships. Experience in developing and [...] Impero is an equal opportunity employer. All aspects of employment, hiring, and promoting are based on merit and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, physical or mental disability, medical condition, pregnancy, gender, sexual orientation, gender identity, or expression. Please be aware that if hired, as part of our Background [...]
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Job am 21.02.2025 bei Jobleads gefunden Vivalyx GmbH: Head of Quality/ QMR • Nordrhein- Westfalen Führungs-/ Leitungspositionen Vivalyx GmbH is looking for a Head of Quality/ QMR At Vivalyx, a medical technology startup based in Aachen, were on a mission to save[...]

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Vivalyx GmbH is looking for a Head of Quality/ QMR At Vivalyx, a medical technology startup based in Aachen, were on a mission to save the lives of those suffering from organ failure. Our [...] play a critical role in ensuring the quality of our medical devices from design and development through to supplier quality management, manufacturing oversight, and risk management. Key responsibilities: Quality Management System (QMS) : Develop, implement, and maintain the QMS in compliance with ISO 13485, covering the scope of design, development, and manufacturing of medical devices. Compliance Auditing: Conduct internal and supplier [...] ability to influence and drive quality initiatives across the organization. Flexibility to adapt to changing environments and requirements. Preferred Qualifications Experience in a medical devices startup environment. Familiarity with supplier quality management and audit processes. Experience as internal and/or supplier auditor. Experience in risk management, particularly with ISO 14971. Experience in regulatory affairs for medical devices. Benefits We provide the opportunity [...]

Job am 19.02.2025 bei Jobleads gefunden

GxP-Consultant

• Neustadt an der Weinstraße, Rhineland- Palatinate Beratungs-/ Consultingtätigkeiten Die Experts Institut Beratungs GmbH ist ein international tätiges Beratungsunternehmen. Unsere Kund:innen sind innovative Start ups, Mittelständler und Konzerne. Unsere Berater:innen, Trainer:innen und Auditor:innen schaffen für ihr Unternehmen unkomplizierte und nachhaltige Lösungen. Wir sind die Umsetzungsberatung für GxP, Transformation, Qualität, Informationssicherheit, Compliance, Projektmanagement und Nachhaltigkeit. Stellenbeschreibung Dies ist ein Remote Job. Zielsetzung der Stelle: Durchführung von GMP-Beratungen im Bereich API, Pharma, Medical Devices, Kosmetik mit Schwerpunkt der Umsetzung von Qualitätssicherungsanforderungen gemäß GMP-Leitfaden, FDA, ANVISA. Mögliche Aufgabenstellungen: Übernahme von Projektmandaten (auch Leitung) im [...]

Job am 17.02.2025 bei Jobleads gefunden Head of Quality/ QMR • Köln, Nordrhein- Westfalen Führungs-/ Leitungspositionen At Vivalyx, a medical technology startup based in Aachen, were on a mission to save the lives of those suffering from organ failure. Our [...] play a critical role in ensuring the quality of our medical devices from design and development through to supplier quality management, manufacturing oversight, and risk management. Key responsibilities: Quality Management System (QMS) : Develop, implement, and maintain the QMS in compliance with ISO 13485, covering the scope of design, development, and manufacturing of medical devices. Compliance Auditing: Conduct internal and supplier [...] to influence and drive quality initiatives across the organization. Flexibility to adapt to changing environments and requirements. Preferred Qualifications Experience in a medical devices startup environment. Familiarity with supplier quality management and audit processes. Experience as internal and or/ supplier auditor Experience in risk management, particularly with ISO 14971. Experience in regulatory affairs for medical devices. Benefits We provide the opportunity [...]

Job am 05.02.2025 bei Jobleads gefunden

Compliance Risk Assessment and Monitoring Specialist m/f/d, Assistant Vice President, Hybrid

• Frankfurt, Hesse Führungs-/ Leitungspositionen Job Description Who we are looking for As the Compliance Risk Assessment and Risk Monitoring Specialist, Assistant Vice President, you will be based in Munich or Frankfurt, Germany, reporting directly [...] required; German fluency is an advantage. Experience in risk assessment methodologies, tools, and techniques. Proficiency in Power Point, Excel, and Word. LEAN, Agile, Six Sigma certifications a plus. Relevant professional certifications (e. g. , CIA, CPA, ACCA, CISA, CFE, statutory auditor, etc. ) a plus. We offer Flexible working time. Work from home days might be possible depending on the role. [...] provide investment servicing, data analytics, investment research trading, and investment management to institutional clients. We make all efforts to create a great work environment. Our benefits packages are competitive and comprehensive. Details vary by location, but you may expect generous medical care, insurance, and savings plans, among other perks. Youll have access to flexible Work Programs to help you match your [...]
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Job am 06.01.2025 bei Jobleads gefunden Senior/ Lead Quality Assurance Manager (m/f/d) • Frankfurt, Hesse Führungs-/ Leitungspositionen Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their[...]

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[...] 500 employees in 26 countries are committed to restoring and maintaining the skins beauty. Would you like to become part of our success story? Then join Merz Aesthetics The following responsibilities are awaiting you: You plan and perform various Clinical medical devices medicinal products project audits against GxP and local regulatory requirements. You create audit plans for the studies, based on [...] Practice, Good Pharmacovigilance Practice (pre-marketing related) , and clinical trials regulations. You host the local and international Notified Body and authorities inspection/ External Audits. You manage CAPA of the RA inspections/ External Audits as well as support inspection readiness/ regulatory compliance status at R D. What we expect from you: You ideally hold a Masters Degree in natural science, pharmacy, or medicine. You have 10 years of professional experience in the field of clinical research oversight and/or management. You have 5 years of professional experience as a QA Auditor and executing a QA Manager role in the pharmaceutical/ medical device industry. You ideally have prior experience developing risk-based quality [...]
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Job am 27.12.2024 bei Jobleads gefunden

Senior GCP Compliance Auditor (all genders) (permanent/ full-time)

• Ludwigshafen am Rhein, Rheinland- Pfalz Work-Life-Balance Company Description Abb Vies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas immunology, oncology, [...] you want to contribute to improving patients quality of life through your expertise? In a challenging work environment that offers opportunities for developing and increasing your own skills? Youve come to the right place Moving mountains together as Senior GCP Compliance Auditor (all genders) (permanent/ full-time) Responsibilities Interpret, explain, and apply the applicable current regulations, guidelines, policies, and procedures. Familiarity with global [...]
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Job gestern bei Neuvoo gefunden Siemens Healthineers AG Senior IT Supplier Auditor (f/m/d) • Erlangen, Bavaria IT. Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy[...]

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[...] the ever-evolving healthcare industry. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Senior IT Supplier Auditor (f/m/d) within IT Provider Management to further strengthen and develop a robust IT supplier audit framework to ensure compliance, regulatory adherence, delivery quality contractual obligations of the delivered services. Choose the best place for your work Within the scope [...] up to senior level management as well driving improvement programs with global IT suppliers. As a good team player, you are self-motivated to drive audit programs with internal and external stakeholders. Our global team: Siemens Healthineers is a leading global medical technology company. 72, 000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated [...]

Job am 01.04.2025 bei Neuvoo gefunden BSI

EU IVD Regulatory Lead

• germany, Führungs-/ Leitungspositionen [...] Regulatory Lead EU Reports to: Head of Notified Body IVDR Location: EU homebased Overview/Purpose of the position: Provide regulatory support to the Head of NB IVDR in the establishment and maintenance of the designations as a NB for the applicable Medical Devices Regulations. Responsible for the conformity assessment certification activities related to the scope of the designations the NB operates under and ensure that the CAB is operating in compliance with the applicable regulatory requirements. Responsibilities Accountabilities: Organisational General Requirements: Support Compliance and Risk, Human Resources and Legal with processes [...] qualification, re-qualifications and authorisations of employees to conduct specified conformity assessment, certification and supporting activities linked to the assigned competence codes; Establish qualification criteria for competence codes; Verify the competence for roles Scheme Manager, Technical Specialist, Certificate Decision Maker, Unannounced Auditor, Clinical Reviewer, Competence Verifier, Document Approver. Process Requirements: Build relationships with authorities, i. e. , the European Commission, the Designating [...]

Job am 01.04.2025 bei Neuvoo gefunden Sonic Healthcare Germany GmbH Co. KG IT Auditor (m/f/d) , IT Auditor (m/f/d) • Berlin IT. IT Auditor (m/f/d) - -Sonic Healthcare is a global healthcare company with a reputation for excellence in laboratory medicine/ pathology, radiology/ diagnostic imaging and[...]

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IT. IT Auditor (m/f/d) - -Sonic Healthcare is a global healthcare company with a reputation for excellence in laboratory medicine/ pathology, radiology/ diagnostic imaging and primary care medical services, with more than 44, 000 employees worldwide. Headquartered in Sydney, Australia, Sonic has grown to become one of the [...] report to the Head of Business Assurance EU, and work closely with the Cybersecurity functions. You will engage with local/ regional IT Departments to support and deliver the rolling Business Assurance/ Internal Audit plan as well as help facilitate IT Compliance projects, specifically in Germany under the KRITIS legislation. You will be a dynamic, resilient and adaptable self-starter, with the ability [...]
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Job am 01.04.2025 bei Neuvoo gefunden BSI Compliance Risk Manager-Medical Devices • germany, Healthcare. Great that youre thinking about a career with BSI Job Title: Compliance Risk Manager-Medical Devices Location: Homebased About the role: As a Compliance Risk[...]

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Healthcare. Great that youre thinking about a career with BSI Job Title: Compliance Risk Manager-Medical Devices Location: Homebased About the role: As a Compliance Risk Manager, you will ensure that BSI achieves compliance to accreditation/ [...] principles and internal auditing principles and practices A good understanding of the application of accreditation/ designation, notified body, product and quality systems standards and requirements. A good understanding of Medical Devices manufacturers or AI Industry QMS assessment techniques. ISO 13485 auditor qualification or capability to gain ISO 13485 auditor qualificationISO 27001/ 42001 auditor qualification or capability to gain ISO 27001/ 42001 [...]

Job am 01.04.2025 bei Neuvoo gefunden KBR LCV EUCOM EW Germany: Associate Quality Assurance Specialist • germany, IT. Title: LCV EUCOM EW Germany: Associate Quality Assurance Specialist Program Summary KBR leads the government services world contingency market by providing responsive, full-service logistics[...]

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[...] in 14 countries. Job Summary As an Associate Quality Assurance Specialist, you will be instrumental in supporting our Quality program by providing specialized technical expertise in various quality-related areas. Your role involves inspection, testing, training, audits, and problem-solving to ensure compliance with contractual requirements and quality standards. You will play a vital role in maintaining and enhancing the quality of our [...] management, and stakeholders in quality assurance tasks. Perform other duties as assigned. Basic Qualifications (Required Education, Experience, Skills, and Certifications) Requires a High School Diploma or equivalent and at least 3 years of Quality Assurance/ Quality Management Experience. Must have Auditor Training. Requires a valid passport with at least 12 months of validity and 6 blank pages. Preferred Qualifications (Preferred Education, [...] Certifications such as ISO 9001, ASQ, Lean, Six Sigma, or similar are advantageous and demonstrate a commitment to quality excellence. Advanced skills with the MS Office Suite. KBR Benefits KBR offers a selection of competitive lifestyle benefits which could include medical, dental, life insurance, AD D, R R, an Employee Support Program and more. We support career advancement through professional training [...]

Job am 01.04.2025 bei Neuvoo gefunden Merz Aesthetics GmbH Senior/ Lead Quality Assurance Manager (m/f/d) , Senior/ Lead Quality Assurance Manager (m/f/d) at Merz Aesthetics GmbH softgarden • Frankfurt, Hesse Führungs-/ Leitungspositionen IT. Senior/ Lead Quality Assurance Manager (m/f/d) at Merz Aesthetics GmbH softgarden View job here Senior/ Lead Quality Assurance Manager (m/f/d) Full Time Hybrid Altenhöferallee[...]

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[...] 500 employees in 26 countries are committed to restoring and maintaining the skins beauty. Would you like to become part of our success story? Then join Merz Aesthetics The following responsibilities are awaiting you: You plan and perform various Clinical medical devices medicinal products project audits against GxP and local regulatory requirements. You create audit plans for the studies, based on [...] Practice, Good Pharmacovigilance Practice (pre-marketing related) , and clinical trials regulations. You host the local and international Notified Body and authorities inspection/ External Audits. You manage CAPA of the RA inspections/ External Audits as well as support inspection readiness/ regulatory compliance status at R D. What we expect from you: You ideally hold a Masters Degree in natural science, pharmacy, or medicine. You have 10 years of professional experience in the field of clinical research oversight and/or management. You have 5 years of professional experience as a QA Auditor and executing a QA Manager role in the pharmaceutical/ medical device industry. You ideally have prior experience developing risk-based quality [...]

Job am 01.04.2025 bei Neuvoo gefunden BSI Medical Device Sterilisation Expert • germany, Healthcare. Great that youre thinking about a career with BSI About the role: Are you a Microbiologist, Sterilisation Engineer, or Quality Manager looking for an[...]

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[...] Are you a Microbiologist, Sterilisation Engineer, or Quality Manager looking for an interesting career change? Then this could be the opportunity for you Here at BSI we hire qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilisation, packaging and microbiological testing outlined under ISO 13485. In this role you will have the opportunity to apply your sterile medical device experience to impact patient safety and help determine which new products go to market. This is a full-time position [...] Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD) / EU Medical Device Regulation (MDR) Ability to travel 40 to 60 via car and plane. ISO 13485 Lead Auditor experience desirable. Quality management experience including significant participation in third party quality audits What we offer: We offer a competitive [...]

Job am 27.03.2025 bei Neuvoo gefunden Intuitive Surgical Global Corporate Auditor (gn) • Freiburg im Breisgau, Baden- Württemberg Accounting. Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology,[...]

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[...] their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, lets advance the world of minimally invasive care. Job Description Primary Function of Position The Global Corporate Auditor will support the execution of an efficient and effective Quality audit program. They will support the internal, external, supplier and clinical audit programs to ensure compliance to the applicable regulatory requirements and standards. This individual will have a clear understanding of applicable laws and regulations in [...] KPIs Qualifications Required Knowledge, Skills, and Experience: ISO certified lead auditor (ISO 9001, ISO 13485 and/or ISO 14155 or ASQ CQA) Minimum 2+ years of FDA/ ISO 13485 lead auditing experience Minimum 5 years of experience in quality in the medical device industry Previous experience conducting internal audit is must Experience conducting supplier and clinical site audit is a plus Quality [...]