What are the responsibilities and job description for the Quality Engineer (Post Market surveillance Analyst) position at Kaygen, Inc.?
The Senior Specialist, Post Market Quality is responsible for supporting the execution and coordination of field actions related to Medical Management Solutions (MMS) within North America, ensuring alignment with regional teams in EMEA, Latin America, and Greater Asia. This position manages field action documentation, supports MMS Field Action Committee meetings, and tracks recall activities to closure, ensuring compliance with global regulations, including FDA expectations and regulatory standards.
Key responsibilities include preparing distribution reports, drafting customer letters, maintaining field action records, and managing MMS-related Canadian recall activities. The role also supports audits, data requests, and participates in post-market surveillance meetings and policy revisions. The jobholder must work cross-functionally with various departments and be adaptable to business needs across different time zones, particularly Pacific Standard Time.
Qualifications :
- BA or BS degree with 1-2 years of relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.
- Preferred experience in post-market surveillance, audits, 21CFR 806, and Canada Recall Regulations.
- Experience with medical devices containing software and familiarity with ERP and QMS systems is a plus.
