
Quality Engineer
- Vicksburg, MI
- $28.85-40.87 per hour
- Permanent
- Full-time
- Interpret and review complex engineering drawings and specifications, applying expert-level understanding of GD&T to assess product and process compliance.
- Support and perform medical product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Characterization (PC).
- Ensure compliance with industry-specific standards, including IATF and ISO 9001, and medical device quality and regulatory requirements.
- Actively participate in new product launches, integrating quality requirements into design, process, and production planning.
- Develop, document, and maintain standard work instructions for inspection, testing, and manufacturing processes.
- Conduct first article inspections (FAI) and evaluate results against design specifications.
- Perform and document risk assessments, process capability studies, and tolerance stack-ups.
- Drive Corrective and Preventive Actions (CAPA) using structured problem-solving tools, such as 8D, 5 Why, and Fishbone.
- Participate in internal and supplier audits, supporting regulatory and customer audits.
- Work cross-functionally with Engineering, Manufacturing, and Supply Chain to resolve quality issues and improve processes.
- Lead or assist with the development of control plans, PFMEAs, and process flow diagrams.
- Analyze nonconformities, trends, and quality data to support continuous improvement initiatives.
- Bachelor’s degree in Mechanical, Industrial, or Manufacturing Engineering.
- 3+ years of experience in a Quality Engineering role within the automotive and medical device industry.
- Proficient in engineering drawing review and GD&T.
- Experience working with IATF and ISO 9001 standards.
- Experience working directly with customers as the main point of contact.
- Familiarity with quality tools and methodologies, including FMEA, SPC, 8D, and MSA.
- Experience with plastic injection molding, IQ/OQ/PQ, statistical analysis, PPAP, and APQP.
- Experience with Statistical Analysis Software.
- Experience with APQP and supplier quality processes.
- Certifications such as CQE (Certified Quality Engineer), Six Sigma Green/Black Belt, or GD&T Professional Certification.
- Experience with precision measurement tools and CMMs.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)