Quality Engineer
Baker IT, Inc. - Saint Paul, MN

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Title: Quality Engineer
(Exempt) (Professional)
Local Only

Description:
Determines manufacturing operation requirements and process parameters. Develops plans to evaluate process repeatability and stability. Utilizes FMEA within process development. Ensures compliance with GMP’s

Job Duties: Experienced practitioner in master validation plans, pFMEA, IQ, OQ, PQ and process monitoring and control. Statistical aptitude sufficient to perform gage r&r, capability assessments, design of experiments, sample size determination, tolerance interval calculations, and SPC. Good teaming skills, as this position is part of a team comprised of other contractors and engineers.
Required
Education Level: Undergraduate Degree in engineering.
Experience involving medical device process development and manufacturing support
Industry Experience: 3 - 5 Years
Written Communication: Excellent technical writing and critical review of other’s documentation.
Desired Education Level: Quality or Reliability Certification
Industry Experience: Greater than 5 years experience in manufacturing process development including remediation and manufacturing site transfer projects.
Written Communication: The ability to take complex concepts and translate them into readily understandable written documentation. The ability to coach other’s on technical writing.
Request Notes: Experience in medical device important. Must be experienced in process validation (IQ, OQ, PQ). Local travel between facilities required (less than 5 miles). This is not a Software Validation position.

Skills:
Education Level: Undergraduate Degree
Industry Experience: 3 - 5 Years
Written Communication: Good
Industry Experience: Greater than 5 Years
www.BakerIT.com


About this company
Since 1993, Baker IT has been a leader in providing technology resources to help our clients gain competitive advantage by employing the...