Senior Quality Engineer

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

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.

Conduct Internal audit, collaborate with teams to resolve findings, generate
needed 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: Include Reference # 144218-6 w/resume.

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

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: