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Principal Quality Engineer - Medical Device
Lead position with a rising Class III medical device company North of Boston.
This requires a BS in Engineering +8 years of medical device quality engineering
About Our Client
Our latest client is a privately held medical device company with multiple major product lines. The devices are class III medical devices and its latest product anticipates an FDA approval after a recently positive FDA panel review last month.
- Lead the Quality Audit system by participating and leading internal audits
- Lead 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
- Candidates must have a minimum Bachelor of Science degree in engineering (I.e. Mechanical, Electrical, Biomedical, Plastics, or Chemical)
- Must have a minimum of 8 years of full-time Quality Engineering experience in the medical device industry.
- Experience in medical device design and manufacturing of capital equipment and sterile disposable medical devices is strongly preferred
- Experience with incoming inspection
- Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
- Local candidates only; no relocation is offered
- Strong experience Quality Auditing to 21 CFR Part 820 and ISO 3485
- Our client is an equal opportunity employer
What's on Offer
- Strong base salary
- Annual bonus
- Leadership position - managing incoming inspection with an opportunity to hire Quality Engineers under him/her
- Life-saving device- these products can be found in hospitals which play a fundamental role in preserving life
- Financial backing, this company has received recent millions in additional funding for its product's commercialization in the US and successes in Europe, Canada, and Australia.
- 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.