Role OverviewThe Senior Quality Engineer will provide Quality Engineering support to ensure quality practices are implemented and maintained across design transfer, inspection, production, and data monitoring. This role leads quality initiatives and projects, supports process and equipment qualification, and ensures compliance with established procedures.
What You Will Do
Provide expertise and general oversight for the management and improvement of Nova Biomedical’s Quality Systems, develop plans to resolve quality issues, mentor quality engineers, and make risk-based decisions confidently.
Why It Might Be a Fit
The ideal candidate will have 7+ years of Medical Device/IVD Experience as a Quality Engineer, knowledge of regulations and standards affecting IVDs and Medical Devices, and excellent oral and written communication skills.
Requirements
- Bachelor's degree or higher in Engineering or the technical sciences
- 7+ years Medical Device/IVD Experience as a Quality Engineer
- Knowledge of regulations and standards affecting IVDs and Medical Devices
- Excellent oral and written communication skills
- Prioritization, and multi-tasking skills
- Detail-oriented, able to read and interpret technical documents
- Ability to exercise judgement in selecting methods and techniques for obtaining results
- Computer literacy including MS Word, MS Excel MS Access
- Statistical Software experience, i.e. Minitab
- Previous experience working with Master Control and/or Power BI a plus
- Auditing experience and certification is preferred
Benefits
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks
- Company subsidized cafeteria
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