Supervisor, Quality Engineering
Steris
- Monterrey, N.L.
- Permanente
- Tiempo completo
- 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
- 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.
- Leads assigned Quality staff to provide Quality technical support to manufacturing and servicing production lines
- Ensure robust production and process controls that are in alignment with production and Lean strategies.
- Align production product and service quality improvement to supplier improvement strategies and tactics.
- Teamwork: Collaborates with others. Works in a professional manner to support team actions.
- 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.
- Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab and Word.
- Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
- Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements.
- 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