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QA Manager-Manufacturing-Frankfurt Main-(m, f, d)
• Frankfurt, Hesse
[...] applicable global regulations, and Quality team members located at the manufacturing facility in Frankfurt. Manage, lead, and direct the efforts of the Frankfurt site Quality team members to ensure that manufacturing related processes and activities comply with the applicable global
medical device regulations (e. g. , FDA, EU, etc) and Sirtex Quality Management System requirements. Host and lead internal and external audits of the manufacturing facility and manage follow-up actions as required. Participate and deploy products or process changes at the manufacturing facility, ensuring compliance to global medical device regulations and Sirtex Quality Management System requirements. Collaborate with other functional teams to identify, investigate, and resolve product quality issues in a compliant and effective manner. Manage, select, train and develop staff as well as conduct performance reviews and performance management activities. Ensure compliant investigations are conducted in a timely manner and in accordance with medical device regulations and Sirtex Quality Management system. Participate in supplier qualification, audit, ongoing monitoring, and supplier improvement [...] in identifying, prioritizing, communicating and resolving quality issues. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE) . Qualifications Minimum of 7 years Manufacturing Quality experience and minimum of 3 years of
supervisor or leadership experience within Medical Device industry or Pharmaceutical/ biotech. Bachelors degree required, preferably in Engineering or Science. Demonstrable competency with the Medical Device Regulation 2017/ 745, 21 CFR 820, EN ISO 13485, and EN ISO 14971, particularly with respect to Quality responsibilities associated with manufacturing related activities. Prior leadership as SME during internal and external audits. Demonstrable competency in developing and implementing QMS procedures compliant with medical device regulations such as FDA 21 CFR, MDR 2017/ 745, EN ISO 13485, etc. Demonstrable competency and prior experience conducting internal audits, supplier audits and supplier qualification activities. Experience with the EU MDR regulation and Post Market Surveillance requirements. Strong English and German written and verbal communication and presentation skills. Competent in [...]
