Senior Quality Engineer

Omega Plastics, Inc. • Clinton Township, MI

21h • Onsite

About The Position

Omega Plastics, Inc. has an opening for a Senior Quality Engineer at 24401 Capital Blvd., Clinton Twp., MI 48036. This is a full-time, salaried position working 40 hours per week, from 9 am to 5 pm, Monday through Friday.

Requirements

• Bachelor’s degree in Biomedical Engineering, or Aerospace Engineering, or Mechanical Engineering, or foreign degree equivalent
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior