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
Main Duties & Responsibilities
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.
Qualifications
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.
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.
Click here for more information: www.trimasbenefits.com
