Regulatory Compliance Engineer
3 days ago
At Enovis Corporation, we are committed to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. As a Supplier Quality Engineer, you will be part of a talented team that drives innovation and excellence in the medical technology industry. Your contributions will have a direct impact on improving patient care and advancing medical technology.
Key Responsibilities:
- Develop and maintain quality management systems and procedures.
- Conduct supplier evaluations and audits to ensure compliance with regulatory requirements.
- Lead and manage corrective actions for supplier-caused product problems.
- Support internal CAPA programs and non-conforming material investigations.
Requirements:
- Bachelor's degree in science or engineering and 3+ years of applicable experience.
- Certification as a Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
- Experience in medical device engineering standards and concepts.
- Knowledge of FDA/GMP, CMDR, MDR, MDSAP, and ISO quality standards.
Estimated Salary Range:$85,000 - $110,000 per year, depending on experience and qualifications.
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