Role OverviewThe Quality Engineer will assist with the growth of our quality department, participating in cross-functional and business teams to improve and develop processes with regulatory compliance requirements of ISO and the FDA.
What You Will Do
Ensure the company meets regulatory obligations, deliver customer confidence through well-performing systems, and participate in quality initiatives to improve the site Quality Management Systems (QMS).
Why It Might Be a Fit
Ideal candidate will have a strong understanding of ISO 13485 QMS processes and USA FDA part 820 regulations, as well as experience preparing for and hosting customer and regulatory audits and inspections.
Requirements
- Bachelor's degree in a technical/scientific discipline
- 4+ years of professional experience in a regulated industry
- Clear understanding of ISO 13485 QMS processes and USA FDA part 820 regulations
- Strong interpersonal and team building skills
- Experience preparing for and hosting customer and regulatory audits and inspections
Benefits
- Competitive salary and bonus compensation
- Medical, Dental, Vision, and HSA plans
- Life, AD&D, STD, LTD plans
- Generous 401k plan with Employer Match and Profit Sharing
- Paid Holidays, PTO, and other leave programs
- Monthly training hour allotment
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