What are the responsibilities and job description for the Quality Engineer position at GForce Life Sciences?
Quality Engineer
12-month contract
Onsite in West Valley City
Key Responsibilities
- Provide quality support to daily production line operations, including decision-making on rejected materials or process deviations.
- Perform software and equipment validations, especially for incoming inspection processes.
- Complete and review part certifications for supplied raw materials.
- Monitor and close Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs).
- Support change management, process validation (IQ, OQ, PQ), and risk management activities.
- Interface with suppliers to resolve quality issues and maintain the Approved Supplier List (ASL).
- Participate in internal and external audits, presenting subject matter expertise when required.
- Review and approve quality documentation related to process and equipment validation.
- Support First Article Inspections and apply statistical methods for continuous improvement.
- Maintain and analyze KPIs for supplier and process quality performance.
- Coach and mentor others on quality topics and best practices.
Qualifications
- Bachelor’s degree in Engineering or a Science discipline.
- Previous experience in a regulated industry (Medical Device, Aerospace, Automotive, etc.).
- Familiarity with ISO 13485, GMP, GDP, and FDA regulations.
- Experience with quality tools and methodologies (e.g., Lean Six Sigma, root cause analysis, risk management).
- Strong attention to detail, organizational skills, and communication abilities.
- Proficient with Microsoft Word, Excel, and PowerPoint.
- Self-starter with strong problem-solving skills and the ability to multitask in a fast-paced environment.
- Experience with validations (IQ, OQ, PQ), incoming inspections, and part certifications.
- Knowledge of statistical techniques, process capability, and inspection sampling plans.
- Ability to collaborate cross-functionally and serve as a strong advocate for quality.
