Role OverviewThe Sr. Quality Engineer is accountable for quality support for devices, products developed and process design to achieve regulatory requirements and industry standards. The incumbent will be capable of self-direction and project management to ensure successful outcomes.
What You Will Do
Provide guidance and Quality oversight, support new product development and existing product sustaining activities, ensure design control documentation and records are maintained, lead and support new product development execution of design control, evaluate design verification results and data, and review and authorize Quality approval for new product and/or device design specifications.
Why It Might Be a Fit
The ideal candidate will have demonstrated knowledge of engineering principles, three years of proven and effective project management skills, and experience in a regulated industry. The role requires a minimum of 4 days of in-office presence per week.
Requirements
- Bachelor’s degree in STEM and five (5) years of engineering experience within a regulated industry, OR Master’s degree in STEM and four (4) years of engineering experience within a regulated industry
- American Society of Quality (ASQ) certification (CQE, CQA, etc)
- Experience in medical device industry
- Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills
Benefits
- Healthcare
- PTO
- Retirement
- Learning budget
- Parental leave
- Wellness
- Visa/relocation
- Remote flexibility
- Stipends
- Bonus/commission
- Paid holidays
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