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Job Title:  Senior Manager, Quality Systems

Req ID:  16538
Job Category:  Quality
Country:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

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 Senior Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards.  The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820.  This role leads the local site(s) efforts focused on product/service quality improvement, supplier quality, new product/service development quality and quality system compliance. The Senior Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. This position also takes the lead in developing, adopting and maintaining state-of-the-art quality practices for multi-site and complex product and service lines. 

Duties
  • Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive Continuous Improvement.
  • Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
  • Work closely with Senior Management to provide strategic direction and development of the organization’s quality strategies and tactics.
  • Provide quality viewpoints and opinions on future product and service development.
  • Provide coaching, mentoring and leadership to the Quality staff.
  • Serve as the site’s Management Representative and lead the organization’s Management Review process.
  • Ensure compliance with appropriate domestic regulatory and international standards and requirements.
  • Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
  • Lead and develop effective production and process controls.
  • Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
  • Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
  • Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
  • Determine supplier qualification risks based upon criticality of component and supplier process capability.
  • The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance. 
  • Perform other duties as assigned
Required Experience
  • Bachelor's degree in Engineering or other related technical field.
  • 10+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
  • 10+ years of experience with medical device or other regulated industries preferred.
  • 10+ years of experience working in an ISO certified environment required.
  • Minimum of 6 years in a Quality leadership role.
  • ASQ, QSR or familiarity with QSR/GMP regulations preferred.
  • Excellent problem-solving skills
  • Focus on identification of potential issues and continuous improvement.
  • Experience working on cross-functional teams and on own initiative.
  • Demonstrated excellent organizational, oral and written communications skills.
  • Must have working experience with Microsoft Office.
  • Experience with statistical analysis software and Visio preferred.

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STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

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.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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