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Quality Process Validation Engineer

Employer
Neuralink
Location
Fremont, CA
Start date
Jul 21, 2022
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As a Quality Process Validation Engineer at Neuralink, you will be a part of the Quality Systems team responsible for supporting cross-functional teams in process validation related to medical devices. You will be in charge of communicating with experts to validate processes like cleaning, sterility, and packaging. Please note that this is not an entry-level position.

Responsibilities:

  • Responsible for medical device cleaning, sterility, and packaging-process validation.
  • Develop, design, and execute validation protocols.
  • Have a working knowledge of 21 CFR 820.
  • Drive Quality Engineering Validation activities designed to make it easier for design engineers to innovate.
  • Be an excellent communicator who can clearly and effectively translate regulatory requirements into action.
  • Have a clear understanding of how to apply risk-mitigation strategies.
  • Have advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management, and Statistical Techniques.
  • Display excellent people skills.

Qualifications:

  • Minimum BS degree; Minimum of 2 years of regulated process validation experience.
  • Very high energy.
  • Extremely good with people.
  • Excellent creative problem-solving skills.
  • Excellent at putting plans into action.
  • Prefer ASQ certification, ie. CQE.

What we offer:

  • An opportunity to change the world and work with some of the smartest and the most talented experts from different fields. 
  • Growth potential. We rapidly advance team members who have an outsized impact. 
  • Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
  • Flexible time off + paid holidays.
  • Equity + 401(k) plan.
  • Commuter Benefits.
  • Meals provided.
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