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; and 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.
Applicants should apply at: https://trimascorp.csod.com/ux/ats/careersite/16/home?c=trimascorp. Include Reference # 144218-6 w/resume. Omega Plastics, Inc. is an equal opportunity/affirmative action employer.
