Quality Assurance Engineer for Medical Equipment
3 days ago
The Quality Assurance Engineer will play a critical role in ensuring the quality of medical devices manufactured by our clients. This is an exciting opportunity for a motivated individual to join our team and contribute to the development of innovative products.
Key Responsibilities:- Support regulatory agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Implement various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.
- Lead in the completion and maintenance of risk analysis.
- Develop various inspection techniques and procedures to ensure product integrity to design specifications.
- Competitive base salary between $80,000-$90,000, depending on experience and skills.
- Bonus opportunity up to 5%.
- Comprehensive benefits package including Medical, Dental, and Vision.
- 15 PTO Days + 10 holidays.
- 401(k) with 3% company match.
- Bachelor's Degree in Engineering or a related field.
- 4+ years of experience in a manufacturing environment, specifically in metal working or machining.
- Project Management and Lean Manufacturing experience.
- Good knowledge of statistical tools and Design of Experiments (DOE).
- Excellent communication and interpersonal skills.
- Working knowledge of ISO 9001:2015, ISO 13485:2015, 21 CFR, and cGMPs.
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