Job Title:  Supervisor, Quality Engineering

Position Summary

The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/values streams.  This role has responsibility for incoming product/component inspection, NCR investigation, production quality and final QC inspection/testing.  The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams.

Duties

• Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. (OOB, SR/Unit, Installation DPU, others)
• Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield).
• Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects.
• Prepare & present quality data on assigned processes/areas at Management Review
• Lead project related with the key QS initiatives defined by Corporate.
• Meet the regulations and special requirements from the certified bodies and customers.
• Production and Pos-Production analysis for site products
• New Product Introduction support to assure compliance with QMS and International regulations applicable.
• Lead assigned Quality staff in effectively managing nonconforming product including proper disposition and recordkeeping.
• Supports process validation activities with the engineering teams.

Education Degree

Required Experience

• 5-8 years of Quality Engineering experience.
• 5-8 years of experience in healthcare, medical device or other regulated industry preferred.
• 5-8 years of experience working within a regulated or certified Quality Management System required.
• 3-5 years of experience with supplier quality.
• 3-5 years of experience in Lean methods.
• ASQ, QSR, or familiarity with QSR/GMP regulations preferred.
• 3-5 supervising/leading employees.
• Bilingual
• Bachelor’s Degree Mechanical, Industrial, or related.
• Lean Manufacturing Certification or related preferred.