Job vor 4 Tagen bei Mindmatch.ai gefunden
SCARLETRED Holding GmbH
Software Medical Device Quality Engineer
• AT- 9
[...] combination products for all phases of the product lifecycle including design, development, manufacture, distribution, and product support processes. Ensure all device and combination product quality and regulatory standards/ requirements are met. Provide quality support for, but not limited to, internal/
external inspections, product submissions/ approvals, CAPA, complaint handling, and change control Represents DQ in support of Scarletredss medical device and combination [...] 13485, ISO 14971, MDR and IEC 62304. Experience with commercial development and regulatory filings Experience working with external manufacturing partners Desired Advanced Degree and Experience working in Pharmaceutical/ Biotech/ Device industry, Software Application Medical Device Engineering background preferred, Quality IT;
Auditor certification. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team [...]