OmegaPlastics, Inc. has an opening for a Senior Quality Engineer at 24401 CapitalBlvd., Clinton Twp., MI 48036. 40 hrs/wk. 9am - 5pm. M-F.
Responsibilities:
Spearhead Non-Conformances, CAPA,SCAR, and customer complaints activities which include root causeinvestigations, material disposition, risk analysis, and implementation ofCorrective Action Preventative Action Plan.
Develop, and review IQ/OQ/PQ ValidationProtocols, Summary Reports, Validation Master Plans for products, andmanufacturing processes per ISO 13485, and 21 CFR 820 regulations.
SupportQuality Management System development by creating Procedures and WorkInstructions in support of ISO13485 and 21CFR820 compliance.
Lead Softwarevalidation projects to include documentation creation - Test Plans, UserRequirement Specification (URS), protocols, Test Method Validation (TMV), andSummary Reports; generate Risk Management Documentation - Process Flow Diagram(PFD), pFMEA, and Control Plan (CP) per ISO14971 for process, product, andsecondary operations.
Review and approve documentation such as Quality Plans,Inspection Reports, Change Controls, and Non-conformances to release for validationand commercial activities.
Support New Product Introduction (NPI) and ProcessDevelopment processes which include feasibility, kickoff, and gate reviews.
Conduct Internal audit, collaborate with teams to resolve findings, generateneeded records and reports.