Job Description

Position Overview

The Sr. Quality Assurance Engineer role provides advanced quality engineering support by leading complex validation, risk management, and change control activities. It ensures regulatory and internal compliance while driving continuous improvement across product development, operations, and supplier management. The position acts as a key technical resource and mentor, promoting quality system harmonization and operational excellence across multiple sites.

Essential Duties

Include, but are not limited to, the following:

  • Lead and execute advanced quality engineering activities including process validation, risk assessments, and supplier quality improvements.
  • Oversee CAPAs, complaints, and audit follow-up activities ensuring timely and effective resolution.
  • Conduct internal and supplier audits, driving corrective actions and continuous improvement initiatives.
  • Provide quality oversight of EQMS documentation to e...

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