Senior Quality Engineer

TriMas Corporation; Clinton Charter Township (MI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Retirement Program

Job summary

A manufacturing company is seeking a Senior Quality Engineer located in Clinton Township, Michigan. The role includes leading Non-Conformance activities, developing validation protocols, and supporting quality management systems. Candidates should have a Bachelor's degree in Biomedical or related engineering, with at least one year of relevant experience in quality assurance. Knowledge of ISO-13485 and 21 CFR-820 is essential. Benefits include medical, dental, vision insurance, flexible spending accounts, and a retirement program.

Qualifications

• Bachelor’s degree or equivalent in related engineering field.
• At least 1 year of experience in quality assurance or related positions.
• Knowledge of ISO-13485 and 21 CFR-820 compliance.

Responsibilities

• Lead activities for Non-Conformances, CAPA, and customer complaints.
• Develop IQ/OQ/PQ Validation protocols and review documentation.
• Support Quality Management System development.
• Conduct internal audits and collaborate to resolve findings.

Skills

ISO-13485 standards

Quality Management Systems

Risk management tools

Measurement System Analysis

Corrective and Preventive Action processes

Minitab

Education

Bachelor’s degree in Biomedical Engineering or related field

Job description

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

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 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.

Qualifications

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.

Benefits

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.