About The Position

Ensure continuous compliance with all regulatory and quality requirements (GMP/FDA-QSR). Conduct internal and external audits and provide training on quality assurance topics. Design and implement inspection, testing, and evaluation methods to ensure product precision and reliability. Halt production processes when identifying non-conforming product conditions. Develop and maintain inspection/testing documentation and specify related equipment and tools. Support vendor management through problem-solving, auditing, and standardizing inspection techniques. Collaborate with suppliers and customers to resolve quality and reliability issues, conduct investigations, and recommend design improvements. Support new product development and validation activities, including product, process, and packaging validation, while adhering to EHS policies.

Requirements

  • Bachelor’s degree in Engineering or a related discipline
  • Up to 2 years of experience in Quality Assurance or a related functional area.
  • Basic knowledge of inspection methods applied in the design and production of electromechanical and/or mechanical equipment.
  • Intermediate level of English.

Nice To Haves

  • Licensed Engineer (EIT or PE) preferred.
  • Quality Assurance training is a plus.

Responsibilities

  • Ensure continuous compliance with all regulatory and quality requirements (GMP/FDA-QSR).
  • Conduct internal and external audits and provide training on quality assurance topics.
  • Design and implement inspection, testing, and evaluation methods to ensure product precision and reliability.
  • Halt production processes when identifying non-conforming product conditions.
  • Develop and maintain inspection/testing documentation and specify related equipment and tools.
  • Support vendor management through problem-solving, auditing, and standardizing inspection techniques.
  • Collaborate with suppliers and customers to resolve quality and reliability issues, conduct investigations, and recommend design improvements.
  • Support new product development and validation activities, including product, process, and packaging validation, while adhering to EHS policies.
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