Senior Quality Engineer
Listed on 2026-07-01
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Process Engineer
Senior Quality Engineer
Omega Plastics, Inc. has an opening for a Senior Quality Engineer. Responsibilities include spearheading 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.
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