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. This role is risponsable for the hiring, development and overall management of his/her Quality team.  Develops and manages work assignments, analyzes and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues.  The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other regulatory standards, as applicable.

Duties

1. Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. (OOB, SR/Unit, Installation DPU, others)
2. 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).
3. 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.
4. Prepare & present quality data on assigned processes/areas at Management Review
5. Meet the regulations and special requirements from the certified bodies and customers
6. Production and Pos-Production analysis for site products
7. New Product Introduction support to assure compliance with QMS and International regulations applicable
8. Lead assigned Quality staff in effectively managing nonconforming product including proper disposition and recordkeeping.
9. Supports process validation activities with the engineering teams.
10. Leads assigned Quality staff to provide Quality technical support to manufacturing and servicing production lines
11. Ensure robust production and process controls that are in alignment with production and Lean strategies.
12. Align production product and service quality improvement to supplier improvement strategies and tactics.

Duties - cont'd

Competencies:

1. Customer Focused: Demonstrates a “Customer first” mindset.  Responds with a sense of urgency.
2. Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
3. Results: Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.  Ability to analyze technical issues.  Ability to cope with change and shifting priorities.Communication: Constructs clear written communication.  Keeps manager and co-workers informed.
4. Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab and Word.
5. Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
6. Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements.

Education Degree

Required Experience

1. 5-8 years of Quality Engineering experience.
2. 5-8 years of experience in healthcare, medical device or other regulated industry preferred.
3. 5-8 years of experience working within a regulated or certified Quality Management System required.
4. 3-5 years of experience with supplier quality.
5. 3-5 years of experience in Lean methods.
6. ASQ, QSR, or familiarity with QSR/GMP regulations preferred.
7. 3-5 supervising/leading employees