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Sr. Quality Design Assurance Engineer - ISO 13485
IQ/OQ/PQ Design validation and verification required
Fast paced company with opportunity to grow
About Our Client
Our client is an innovative medical device OEM. They are currently looking to hire a Sr. Quality Design Assurance Engineer to join the team and report to the VP of Quality
The Sr. Quality Design Assurance Engineer will have responsibilities that include:
- Ensures project teams are utilizing Medical Quality Systems and appropriate regulation and industry standards throughout the product development process.
- Ensures outside supplier quality systems meet company requirements and coordinates any activities with the supplier as needed.
- Conducts risk analysis for products under development
- Develops verification and validation test protocols.
- Develops product submission documentation if required by the customer.
The Successful Applicant
- Bachelor's Degree in Engineering is required
- Local candidates only
- Minimum four (4) years of full time medical device product design and development experience
- Demonstrated ability to bring products from concept to market.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Expected to attend project meetings and present specific aspects of Quality Assurance and Quality Engineering assignments.
What's on Offer
- Excellent base salary for mid-level position
- Annual discretionary bonus
- Strong benefits - 401k matching, medical, dental, life
- Work with top-end medical device manufacturers as customers