Senior Quality Engineer

TriMas Packaging Group; Michigan; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Accounts

Life Insurance

Retirement Program

EAP

Job summary

Omega Plastics, Inc. invites applications for a Senior Quality Engineer at Clinton Township, MI, on-site.

The role focuses on leading non-conformances, CAPA, SCAR, and customer complaints with root-cause investigations, material disposition, risk analysis, and implementing corrective actions. You will develop IQ/OQ/PQ validation protocols per ISO 13485 and 21 CFR 820, support QMS with procedures and work instructions, and lead software validation and risk management documentation, contributing

Qualifications

• Bachelor's degree in Biomedical Engineering, or Aerospace Engineering, or Mechanical Engineering, or foreign degree equivalent.
• 1 year of experience in Quality Engineer and/or QA/RA Specialist and/or quality assurance positions.
• Experience with ISO-13485 standards and 21 CFR-820 regulatory compliance; ISO 14971 and risk management (pFMEA, CP/Cpk, Control Plans).
• Knowledge of MSA, Gage R&R, Process Capability Studies; Corrective and Preventive Action (CAPA) processes; QMS document control and internal audits.

Responsibilities

• Lead Non-Conformances, CAPA, SCAR, and customer complaints activities including root cause investigations and corrective actions.
• Develop, and review IQ/OQ/PQ Validation Protocols and Validation Master Plans for products and manufacturing processes per ISO 13485 and 21 CFR 820.
• Support Quality Management System development by creating Procedures and Work Instructions for ISO 13485 and 21 CFR 820 compliance.
• Lead Software validation projects: Test Plans, URS, protocols, TMV, and Summary Reports; generate risk management docs per ISO 14971.
• Review and approve Quality Plans, Inspection Reports, Change Controls, and Non-conformances for release.
• Support New Product Introduction (NPI) and Process Development including feasibility and gate reviews.
• Conduct internal audits and coordinate with teams to resolve findings and generate required reports.

Skills

Quality Engineering

Regulatory compliance

Risk management

Minitab

Education

Bachelor's degree in Biomedical Engineering or Aerospace Engineering or Mechanical Engineering

Tools

Minitab

Job description

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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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. 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.

Omega Plastics, Inc. is an equal opportunity/affirmative action employer.

Benefits

• 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
• Other Voluntary Benefits