Senior Quality Engineer

Senior Quality Engineer

Company:
Omega Plastics Inc

Primary

Location:

24401 Capital Blvd, Clinton Township, MI 48036 USA

Workplace Type:
On-site

Employment Type:

Salaried | Full-Time

Function:
Engineering

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

• 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. 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 ISO
  13485 and 21
  
  CFR
  820 compliance.
• Lead Softwarevalidation 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 ISO
  14971 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, generateneeded records and reports.

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.

Omega Plastics, Inc. is an equal opportunity/affirmative action employer.

• 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