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Senior Quality Engineer - Medical Device
Seeking degreed medical device quality engineers with a strong CAPA background.
Our latest client is a private class II medical device company based in Andover.
About Our Client
Our latest client is a privately held medical device company with multiple major product lines. These product lines all have CE Marks in Europe, Canada, and Australia with great financial backing. The company is expecting its first FDA approval this spring.
- Supports the Quality Audit system by participating and leading internal audits
- Supports New Product Development projects
- Manages the Corrective and Preventive Action (CAPA) system
- Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews
- Manages the Quality Inspection team; provides daily guidance, on-going-feedback and manages performance
- Recommends and implements potential improvements or enhancements to quality systems and processes
- Leads Quality aspects of the Supplier Management process, e.g., participate/lead supplier audits
The Successful Applicant
- Bachelor's degree in Engineering is required.
- Local candidates only.
- Must have a minimum of 4 years of fulltime quality engineering experience in the medical device industry.
- Strong experience Quality Auditing to 21 CFR Part 820 and ISO 3485
What's on Offer
- Strong base salary
- Supervisory role - incoming inspection
- Growth company- this organization is expecting to double its size over the next few years
- Great benefits package - annual bonus, matching 401k, medical, dental, life.