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Quality Manager

Date: 07-Jan-2019

Location: Bishop's Stortford, HRT, GB, CM23 3LJ

Company: Steris Corporation

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.

 

The 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 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 may include oversight of more than one location.

 

  1. Lead the site(s) Quality staff to ensure compliance to the overall Quality Management System and to drive Continuous Improvement.
  2. Provide coaching, mentoring and leadership to the Quality staff.
  3. Serve as the Management Representative and lead the Management Review process.
  4. Ensure compliance with appropriate domestic regulatory and international standards and requirements.
  5. Lead the organization's product and/or service quality improvement process; including data analysis, improvement projects to improve key internal and external metrics.
  6. Ensure the site has effective production and process controls.
  7. Manage the complaint handling processes to ensure customer responsiveness and product and process improvements.
  8. Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
  9. 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.
  10. Determine supplier qualification risks based upon criticality of component and supplier process capability.  
  11. Perform other duties as assigned

 

  1. 8-12 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
  2. 8-12 years of experience with medical device or other regulated industries preferred.
  3. 8-12 years of experience working in an ISO certified environment required.
  4. Minimum of 2 years in a Quality leadership role.
  5. ASQ, QSR or familiarity with QSR/GMP regulations preferred.
  6. Bachelors Degree

 

In a numbered list, describe specific skills and/or business competencies:

  1. Excellent problem-solving skills
  2. Focus on identification of potential issues and continuous improvement.
  3. Experience working on cross-functional teams and on own initiative.
  4. Demonstrated excellent organizational, oral and written communications skills.
  5. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
  6. Experience with statistical analysis software and Visio preferred.

 

 

 

 

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Position Summary

Duties

Duties - cont'd

Education Degree

    Required Experience

     

    STERIS plc is a $2B+, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.

    STERIS strives to be an Equal Opportunity Employer.