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Job Title:  Director, Customer Quality

Req ID:  19691
Job Category:  Quality
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060

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

Join a collaborative and dynamic team of Quality professionals. In this role you will be leading the Quality Systems for the consumable business, including all consumables for healthcare and life sciences. This is a significant, highly visible role with extensive interaction with the various P and L leaders of the business. In this role, you must have working knowledge of chemical processing or manufacturing of products utilized in the medical or life sciences industry. 

The Quality Director is responsible for leading multiple manufacturing plants in the execution of the overall STERIS Quality System. This position is principally responsible for manufacturing quality system execution to drive product quality improvement and to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards. The Quality Director will lead teams of quality managers and engineers responsible for product and service quality, supplier quality, new product/service support, continuous improvement support and quality system execution.   

What you will do

•    Ensure site level compliance to appropriate ISO, FDA and other applicable regulatory standards.
•    Drive strategies and methods to continuously improve consumable  product quality performance.  
•    Establish clear and consistent quality measurement systems in order to monitor and drive results.
•    Lead quality planning and the execution of assigned New Product(NPD) projects to achieve targeted quality deliverable adherence. 
•    Drive targeted supplier quality improvement efforts and oversees supplier evaluation, approval and control for assigned manufacturing sites. 
•    Assist in the continuous improvement and standardization of quality system procedures and monitor effectiveness. 
•    Support the reliability function by integrating design for reliability tools and techniques within the local projects. 
•    Lead quality planning efforts through cross-functional teaming at a site level.
•    Support the New Product Development process and projects to ensure projects attain cost, quality and delivery objectives.
•    Direct local staff on planning sequential and concurrent quality activities.  Establish planning and monitoring tools and techniques.
•    Provide Quality viewpoints and opinions in planning and specifying existing and future products.
•    Assist in the development of the Quality budget.  Help to ensures resources are adequate to fully support the Quality System.
•    Take ownership of all local quality issues, projects and development activities.  Work closely with the site’s Senior Management Teams to provide strategic direction and development of the manufacturing sites product quality strategies and tactics.

•    Manage and provide direction to a teams of quality professionals both at manufacturing sites, with responsibility for hiring, performance management, appropriate staffing and deployment of resources.
•    Assure that local sites maintain and improve operational and quality systems to remain in a state of compliance to appropriate ISO, FDA and other applicable regulatory standards.
•    Work closely with the regulatory function to ensure compliance to appropriate ISO and FDA standards; plans for and assists in the management of external audits. 
•    Lead manufacturing site quality teams to ensure alignment to operations, support of Lean efforts and drive quality improvement performance for products, services and processes across the sites.    

Required Experience

•    Bachelor's degree in Chemistry, Biology, Microbiology, Chemical Engineering or related technical degree required. (Major must be in science or engineering related discipline)
•    Advanced degree preferred.
•    Must have experience in manufacturing of medical products. Consumables experience highly preferred with a focus on one or more of the following: cleaning chemicals/detergents, biologial or chemical indicators, pharmaceuticals, etc.
•    10 + years of experience with increased responsibility leading quality system and product quality improvement efforts.  Exceptional leadership manifested through organizing and motivating teams toward their respective goals by employing hands-on management.
•    A solid quality foundation indicated by a demonstrated understanding of Lean/Six Sigma, quality system and product/process improvement methodologies.   
•    Solid business acumen and proven ability to build and lead process and product improvement strategies and results.
•    Strong expertise in analytical methods, quality systems and continuous improvement methods. 
•    Excellent interpersonal, as well as verbal and written communication skills in order to develop and maintain rapport and effective internal and external relationships to support business success. 


What STERIS Offers

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.



STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.