Product Quality Assurance Specialist
1 day ago
Our client is a renowned medical device manufacturer with a global presence, serving well-known OEMs such as Stryker and Medtronic. They are seeking a Quality Assurance Engineer to join their rapidly expanding Quality team in the Saint Charles area.
Job DescriptionThe successful candidate will be responsible for:
- Supporting regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
- Implementing various product and process improvement methodologies.
- Reviewing and approving changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and other documentation.
- Leading risk analysis and ensuring compliance with relevant regulations.
- Developing inspection techniques and procedures to ensure product integrity to design specifications.
The ideal candidate will possess relevant Quality Assurance Engineering experience, a Bachelor's degree in a science-related field, and at least 3 years of experience in a Cleanroom environment. Strong Medical Device Manufacturing knowledge and excellent communication skills are also essential.
What We OfferWe provide a competitive base salary between $80,000-$95,000, depending on experience and skills, as well as bonus opportunities up to 5%. Our comprehensive benefits package includes Medical, Dental, and Vision coverage, Life and AD&D insurance, Short-term disability coverage, 15 PTO days + 10 holidays, and a 401(k) plan with a 6% company match.
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