Experteer OverviewYou will lead a Quality Engineering team to improve process and product quality across production lines, driving key quality metrics and regulatory compliance. You will manage NCR investigations, inspections, and customer-facing quality performance while partnering with Lean/CI resources to sustain improvements. The role emphasizes developing talent, implementing data-driven problem solving, and aligning quality initiatives with supplier and manufacturing strategies. This is a mission-driven role focused on delivering robust quality control in a regulated environment.
Responsibilities
- Lead the quality team to improve internal production quality and customer-facing metrics
- Drive data analysis and improvement projects to reduce defects and improve FPY and DPU
- Ensure robust process controls aligned with Lean and production strategies
- Coordinate with supplier quality and implement supplier improvement actions
- Develop team objectives and support talent development
- Contribute to Quality System compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR
- Manage inspection activities for incoming product/components and final QC testing
- Analyze quality performance data and escalate issues as needed
Qualifications
- 5-8 years of Quality Engineering experience
- 5-8 years in healthcare, medical device or regulated industry preferred
- 3-5 years in supplier quality
- 3-5 years in Lean methods
- ASQ, QSR, or familiarity with QSR/GMP regulations preferred
- 3-5 years supervising/leading employees
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