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Senior Quality Engineer

Location:

Santa Clara, United States

Work type:

Direct Hire

Business sector:

Medical Device

Job reference:

424

Advertiser:

Tyler Snyder

Talent is working with a medical device company that is attempting to treat cardiovascular disease, while focusing on calcification. If you want to make a lasting impact by helping to develop a game-changing technology, a career with this company could be right for you!

Our client is looking for a motivated candidate to be a Senior Quality Engineer. This person will provide and develop solutions, develop protocols for design/process, including those related to verification or validation activities.

(Typical shift starts at 2:00 pm)

  • Design/implement methods and procedures for inspecting, testing and evaluating accuracy. (products, components, sub-assemblies and/or production equipment)
  • Prepare documents for inspection/testing procedures, development studies, validation protocols/reports, quality plans and product defect investigation.
  • Provide guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
  • Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project.
  • Familiar with FDA documents and ISO/ASTM standards related to quality and the medical device industry is a plus.
  • Assess if components, and products meet specifications and can initiate, investigate and resolve non-conformances while working with a multi-disciplinary team.
  • Participate/take the lead role in developing the risk management plan as new projects transition into manufacturing.

 

Requirements

  • BS in a field related engineering (5-8 years experience); or MS in a field related engineering discipline (4–6 years experience).
  • Experience in the medical device industry preferred.
  • Certification and/or license is an asset.
  • Certified Quality Engineer would be an asset.

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