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Sr Quality Assurance Engineer

2 months ago

Santa Clara, California, United States Cordis Full time

Job Title: Senior Quality Assurance Engineer at Cordis

The Senior Quality Assurance Engineer collaborates with internal departments to efficiently deliver safe and effective medical device designs for manufacturing in accordance with Cordis policies and procedures.

Responsibilities:

Act as CAPA Coordinator to ensure timely CAPA processes.Manage the training process and ensure compliance with internal requirements.Support in addressing and resolving issues related to inspection processes.Prepare and coordinate regulatory filings like IDE, PMA, and Design Dossier submissions.Review and approve complaint, CAPA, Non-Conformances, and Audit Observation investigations.Participate in audits and project team meetings.Provide ongoing quality system support and improve processes.Lead quality initiatives and participate in product risk assessments.Qualifications: Bachelor's Degree in a related discipline with at least 4 years in the medical device/pharmaceutical field. Expertise in FDA Medical Device Quality system Regulation, MDD 93/42/EEC, and ISO Experience with MDRs, IDEs, PMA, and 510(k) filings preferred. Strong communication and interpersonal skills, ability to create process improvements. CQE and Auditor Certification preferred. Benefits include 401(k), Medical, Dental, Vision Insurance, Life insurance, and Paid time off. Cordis is an equal opportunity employer dedicated to fostering an inclusive work environment.