Overview 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 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 Benefits corporate premio
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