Staff Engineer, Design Quality (CDx/FDA)
About The Position
The Staff Design Quality Engineer is a highly experienced technical quality leader responsible for quality oversight of complex IVD medical device development programs, high-risk changes, and technically demanding validation and design transfer activities. This role applies advanced judgment to product quality, risk, and compliance decisions and serves as a senior subject matter expert for design controls, risk management, validation strategy, design changes, and development documentation. The role routinely influences program direction, mentors others, and helps resolve the most difficult technical quality issues.
Requirements
- Highly experienced technical quality leader
- Expertise in IVD medical device development programs
- Expertise in high-risk changes
- Expertise in validation and design transfer activities
- Advanced judgment in product quality, risk, and compliance decisions
- Senior subject matter expert for design controls
- Senior subject matter expert for risk management
- Senior subject matter expert for validation strategy
- Senior subject matter expert for design changes
- Senior subject matter expert for development documentation
Responsibilities
- Quality oversight of complex IVD medical device development programs
- Quality oversight of high-risk changes
- Quality oversight of technically demanding validation and design transfer activities
- Apply advanced judgment to product quality, risk, and compliance decisions
- Serve as a senior subject matter expert for design controls, risk management, validation strategy, design changes, and development documentation
- Influence program direction
- Mentor others
- Help resolve the most difficult technical quality issues
Benefits
- Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours
- Best-in-class well-being programs
- Annual, no-cost health assessment program Blueprint for Wellness®
- healthyMINDS mental health program
- Vacation and Health/Flex Time
- 6 Holidays plus 1 "MyDay" off
- FinFit financial coaching and services
- 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
- Employee stock purchase plan
- Life and disability insurance, plus buy-up option
- Flexible Spending Accounts
- Annual incentive plans
- Matching gifts program
- Education assistance through MyQuest for Education
- Career advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
