Quality Engineer
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Quality Engineer
Ref No.: 18-00098
Location: Gloucester, Massachusetts
Position Type:Contract
Experience Level: 5 Years
Start Date: 01/16/2018
Job Description:
  • 6-8 years of Quality engineering experience.
  • Quality Engineering experience in Medical Devices (at least in Class I & II) at least 3 years.
  • Full Quality System Knowledge.
  • Extensive Gage R&R experience.
  • Process FMEA.
  • Process Control Plan
  • Measurement System Analysis Studies (Gauge R&R).
  • Process Capability Analysis (Cpk).
  • Process Qualification (e.g. IQ, OQ, PQ).
  • First Article Inspection (FAI).
  • First Production Inspection (FPI).
  • Critical to Quality (CTQ).
  • Supplier Corrective Action Request (SCAR).
  • Incoming inspection Plan.
  • Remediation Planning.
  • 21 CFR 820
  • ISO 13485
  • Primary Skills:
  • Quality Engineering, Quality Compliance and Project Management
Secondary Skills:
  • Must possess strong Critical Thinking capabilities that can identify the best quality system/method solutions.
  • Needs to anticipate Philips customer needs for each assigned project, and reject any excessive requirements.
  • Needs to be very comfortable with the amount of customer interface as it will be significant and extensive.
Educational Qualifications:
  • Mechanical Engineering