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

• 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 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 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, generate needed records and reports.

Bachelor’s degree in Biomedical Engineering, Aerospace Engineering, Mechanical Engineering, or foreign degree equivalent, plus at least 1 year of experience in Quality Engineer, QA/RA Specialist, 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.

Benefit offerings include 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, and Other Voluntary Benefits.