Senior Supplier Quality EngineerWe're looking for a Senior Supplier Quality Engineer (SQE II) to join a cross-functional team supporting supplier quality, manufacturing, and engineering.
This role is a great fit for someone who enjoys hands-on problem solving, supplier development, corrective actions, and working closely with engineering and operations teams in a regulated manufacturing environment.
Key Responsibilities- Partner with Engineering, Operations, and Supplier Quality teams to investigate and resolve supplier-related issues
- Lead and support Corrective and Preventive Actions (CAPA) and nonconformance investigations
- Support supplier development and performance improvement initiatives
- Monitor supplier quality from component acquisition through the manufacturing process
- Participate in supplier audits and assessments to ensure GMP and quality standards are met
- Evaluate supplier processes and provide feedback to improve quality and performance
- Support quality system compliance, including change control, deviations, and nonconformances
Required Qualifications- Bachelor's degree with 4+ years of relevant experience, or an advanced degree with 2+ years of relevant experience
- Experience with CAPA, nonconformance, change control, deviations, and GMP
- Experience using TrackWise or a similar QMS
- Hands-on product problem-solving experience
- Technical engineering background in Mechanical, Industrial, Operations, Biomedical Engineering, or a related field
- Experience working in a regulated manufacturing environment
Preferred- Lean Six Sigma Yellow Belt certification
- Green Belt certification
- Supplier auditing or supplier development experience
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