What are the responsibilities and job description for the Quality Engineer II - Medical Devices, Post-Market position at Cambridge Executive Recruiters Inc?
Established publicly-held medical device catheter manufacturer is looking for a Quality Engineer II to add to their Post-Market Quality Engineering / Complaints Analysis team.
Responsibilities
- Perform Returned Goods and failure analysis on returned products
- Perform Complaints Investigations & Ensure complaints are prioritized based on patient, product, and compliance risk.
- Perform Failure problem identification, resolution, loss reporting and continuous improvement
- Design and implement methods for process control, process improvement, testing and inspection
- Lead continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
- Develop, execute, and analyze quality reporting measures
- Lead / Participate the Product Experience Review (PER) and Quality System Management Review for the Post Market Surveillance Process
- Compile quality metrics, QA logs and databases, reports for posts-market activities.
Qualifications
Full-Time Permanent Position
Full Benefits (Medical, 401K Match, tuition reimbursement)
This is an on-site position (NOT Hybrid).
Local Candidates preferred, however well-qualified candidates from outside the area may also be considered.
US Citizen or candidates with Work Authorization that don't need sponsorship preferred