Manufacturing Quality Engineer

2 days ago


Brooklyn Park, Minnesota, United States Cypress HCM Full time
About the Role

Cypress HCM is seeking a highly skilled Manufacturing Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.

Key Responsibilities
  • Support R&D Design and Engineering Activities

Collaborate with our R&D team to review and provide input on new design specifications, ensuring they meet quality and manufacturability standards.

Work with Contract Manufacturing Companies

Partner with our contract manufacturing partners to resolve non-conformities, conduct root cause investigations, and implement corrective actions.

Develop Process Documentation and Quality Control Plans

Develop and maintain process documentation, including PFMEAs and Quality Control Plans, to ensure compliance with regulatory requirements.

Define Operation Specifications and Inspection Tools

Work with our R&D team to define operation specifications and develop inspection tools and equipment to ensure product quality.

Write, Review, and Implement Quality Procedures

Develop, review, and implement quality procedures to ensure compliance with regulatory requirements and industry standards.

Verify Product Compliance

Verify that our products meet applicable standards and regulatory requirements.

Requirements
  • Bachelor's Degree in Engineering or Life Sciences
  • Knowledge of Medical Devices Standards and Regulation (FDA 21 CFR part 820)
  • 5+ Years of Quality Engineer Experience in Contract Manufacturing
  • Knowledge of Medical Device Development Activities (NPD / NPI)
  • Excellent Communication and Interpersonal Skills
  • Ability to Work Independently
What We Offer

Cypress HCM offers a competitive salary range of $90-$110K base salary, plus quarterly bonuses. We are an equal opportunities employer and welcome applications from diverse candidates.



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