Senior Quality Engineer

TriMas CorporationClinton Township, MI
Onsite

About The Position

Omega Plastics, Inc. has an opening for a Senior Quality Engineer at 24401 Capital Blvd., Clinton Twp., MI 48036. 40 hrs/wk. 9am - 5pm. M-F.

Requirements

  • Bachelor’s degree in Biomedical Engineering, or Aerospace Engineering, or Mechanical Engineering, or foreign degree equivalent, plus of 1 year of experience in Quality Engineer and/or QA/RA Specialist and/or quality assurance positions.
  • Experience must include: ISO-13485 standards and 21 CFR-820 regulatory compliance; ISO 14971 and risk management, such as pFMEA, Control Plans, and Process Flow Diagrams; Measurement System Analysis (MSA), Gage R&R, Process Capability Studies (Cp, Cpk), and use of tools like Minitab; Corrective and Preventive Action (CAPA) processes, utilizing tools such as 5 Whys, 8D, Fishbone, and DMAIC; and Quality Management Systems (QMS), including execution of internal audits, audit readiness support, and document control in compliance with cGMP and ISO standards.

Responsibilities

  • Spearhead Non-Conformances, CAPA, SCAR, and customer complaints activities which include root cause investigations, material disposition, risk analysis, and implementation of Corrective Action Preventative Action Plan.
  • Develop, and review IQ/OQ/PQ Validation Protocols, Summary Reports, Validation Master Plans for products, and manufacturing processes per ISO 13485, and 21 CFR 820 regulations.
  • Support Quality Management System development by creating Procedures and Work Instructions in support of ISO13485 and 21CFR820 compliance.
  • Lead Software validation projects to include documentation creation – Test Plans, User Requirement Specification (URS), protocols, Test Method Validation (TMV), and Summary Reports; generate Risk Management Documentation – Process Flow Diagram (PFD), pFMEA, and Control Plan (CP) per ISO14971 for process, product, and secondary operations.
  • Review and approve documentation such as Quality Plans, Inspection Reports, Change Controls, and Non-conformances to release for validation and commercial activities.
  • Support New Product Introduction (NPI) and Process Development processes which include feasibility, kickoff, and gate reviews.
  • Conduct Internal audit, collaborate with teams to resolve findings, generate needed records and reports.

Benefits

  • Medical Insurance and Prescription Drugs
  • Dental Insurance
  • Vision Insurance
  • Flexible Spending Accounts
  • Life Insurance
  • Short-Term Disability
  • Long-Term Disability Insurance (for eligible employees)
  • Employee Assistance Plan (EAP)
  • Paid Time Off (may include vacation and sick time)
  • Retirement Program
  • Other Voluntary Benefits
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