Senior Quality Engineering Leader (Mentor, OH, US, 44060)

Steris Corporation•Mentor, OH

36d•$90,738 - $117,425

About The Position

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. 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 responsible for the hiring, development, and overall management of his/her Quality team. This individual 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. Relocation assistance available

Requirements

Bachelor's Degree (Engineering or related technical field) with minimum 5 years of Quality Engineering experience
Minimum 5 years of experience working within a regulated or certified Quality Management System
Minimum 3 years of experience with supplier quality
Minimum 3 years of experience in Lean methods
Minimum 3 years supervising/leading employees
Customer Focused: Demonstrates a "Customer first" mindset, responds with a sense of urgency
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

Nice To Haves

Minimum 5 years of experience in healthcare, medical device, or other regulated industry
ASQ, QSR, or familiarity with QSR/GMP regulations

Responsibilities

Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics.
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.
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.
Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy.
Lead the Team's talent development processes and knowledge development.
Assume other duties as assigned.