Quality Assurance Specialist

2 days ago


Vista, California, United States DJO Global Full time
About the Role:
As a Supplier Quality Engineer at Enovis Corporation, you will play a crucial part in driving the medical technology industry forward through transforming patient care and creating better patient outcomes. This role involves implementing and performing Supplier Quality Engineering activities at our company's manufacturing location, ensuring external safety, quality, and compliance with complex company standards and government regulations.

Key Responsibilities:
  • Develop and implement quality assurance protocols and methods.
  • Conduct supplier evaluations and audits to ensure compliance with regulatory requirements.
  • Initiate 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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