Senior Quality Engineer

TriMas Corporation•Clinton Township, MI

2d•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. 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.

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.