- Bachelor's degree in engineering or a science-related degree
- 2+ years of experience in the Medical Device industry
- Knowledge of ISO and FDA requirements: ISO 13485, FDA 21 CRF Part 820
- Ensure that medical devices meet regulatory requirements and meet the highest standards of quality
- Developing, implementing, and maintaining the Quality Management System to ensure compliance with regulatory requirements and standards
- Managing relationships with suppliers and ensuring that all materials and components used in the manufacturing of medical devices meet quality standards
- V&V, CAPA, non-complaint, and continuous improvement processes
- Train and lead team of Quality Engineers
- Competitive Salary: $75k - $120k
- Company Benefits such as:
- Employer Medical Plan
- Relocation Assistance
- PTO & Paid Holidays
- 401k with company match
- Tuition Reimbursement
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Quality Engineer - Cleveland, United States - Lumicity
Description
Exciting Quality Engineer Opportunity with a fast-growing Medical Device Company
**This is not a Software Quality Engineering position and only open to US permanent residents/green card holders**
My client is a Medical Device company looking for a Quality Engineer that has extensive experience in the Medical Device Industry. The ideal candidate is someone who has a strong quality engineering background with Medical Device industry.
This is a great leadership and management opportunity with a company that prioritizes career-growth and has an exciting future within the Medical Device Industry.
Qualifications
Responsibilities
Benefits