The Staff Quality Engineer will work at the intersection of product quality, regulatory compliance, and data-driven decision making, supporting post-market engineering activities and leading improvements across systems and processes.
Requirements
- Review customer complaints and determine reportability to regulatory authorities
- Support preparation and submission of Medical Device Reports (MDRs) and international vigilance reports
- Lead investigations into post-market product issues and implement design and engineering changes
- Partner with engineering teams to implement and validate design and engineering changes
- Act as the post-market quality owner for the Tables Product Line
- Partner with sales teams and healthcare professionals to gather complete complaint data
- Develop customer response letters aligned to investigation findings and regulatory requirements
- Build and maintain dashboards and reports using data from systems
- Author and review post-market surveillance plans and reports
- Lead risk management activities and quality system improvements
Benefits
- Medical, dental, and vision benefits
- 401(k) plan
- Life insurance
- Disability insurance
- Paid time off