Job Description

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

• BS or MS degree in Mechanical, Biomedical, or Manufacturing Engineering
• 2-3+ years' of medical device manufacturing/quality engineering experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving
• Excellent written and verbal communication skills
• Knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems

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

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