Supervisor, Quality

Steris Corporation•Mentor, OH

31d•Onsite

About The Position

The Quality Supervisor leads a team of Quality specialists, technicians or inspectors focused on incoming product/component inspection, final QC inspection/testing of products, complaint investigation, NCR investigation, or production floor quality support. The Quality Supervisor develops and manages work assignments, analyzes and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. 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.

Requirements

Bachelor’s Degree (Engineering/Scientific)
Minimum 4 years of production Quality and/or Quality Management Systems experience
Minimum 4 years of experience in healthcare, medical device or other regulated industry
Minimum 2 years of experience leading a team and/or supervising employees
PC experience and working familiarity of common desktop applications including Excel and Word
Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements

Nice To Haves

ASQ, QSR, or familiarity with QSR/GMP regulations preferred
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
Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction

Responsibilities

Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management.
Lead and manage assigned Quality staff to effectively execute site calibration and maintenance records; training records; DHR records and environmental control monitoring.
Lead and manage assigned Quality staff to effectively execute QC inspection procedures and capture associated non conformances.
Lead and manage assigned Quality staff to effectively investigate non conformances.
Lead the team in providing effective production floor Quality support.
Lead and manage assigned Quality staff in effectively managing nonconforming materials including proper disposition and recordkeeping.
Establish individual and team objectives to attain key metric performance and ensure alignment to overall Quality strategy.
Analyze and trend Quality data to identify and drive product/service and process improvements.
Lead the Team’s talent development processes and knowledge development.
Assume other duties as assigned.