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Senior Quality Engineer - Medical Device
This position would lead/support Quality Systems & New Product Development.
Candidates require a BS Engineering + 6 years of Med Device Quality experience.
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
- Candidates must have a minimum Bachelor of Science degree in engineering (I.e. Mechanical, Electrical, Biomedical, Plastics, or Chemical)
- Must have a minimum of 6 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
- Must have 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
- Growth role, this position has opportunity to become a manager
- Life-saving device- these products can be found in hospitals which play a fundamental role in preserving life
- 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.