Senior Manager Quality System

3 days ago

Minneapolis, Minnesota, United States STERIS Full time
Senior Quality Manager Job Description

At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions. We are seeking a highly skilled Senior Quality Manager to lead our quality improvement initiatives and ensure compliance with regulatory standards.

Key Responsibilities:
  • Lead the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
  • Develop and implement quality strategies and tactics in collaboration with Senior Management.
  • Provide quality viewpoints and opinions on future product and service development.
  • Coach, mentor, and lead the Quality staff to achieve excellence in quality management.
  • Serve as the site's Management Representative and lead the organization's Management Review process.
  • Ensure compliance with domestic and international regulatory standards and requirements.
  • Lead the organization's continuous improvement process, including data analysis, improvement projects, and process capability to improve key metrics.
  • Develop and implement effective production and process controls.
  • Manage complaint handling processes to ensure 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.
Requirements:
  • Bachelor's Degree in Engineering or related technical field.
  • Minimum of 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
  • Minimum of 10 years of experience with medical device or other regulated industries preferred.
  • Minimum of 10 years of experience working in an ISO certified environment required.
  • Minimum of 6 years in a Quality leadership role.
  • Must fulfill the experience requirements listed in Article 15 of the EU MDR (PRRC).
  • 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 PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
  • Experience with statistical analysis software and Visio preferred.
What STERIS Offers:
  • Competitive pay.
  • Annual merit bonus and incentive plans.
  • Medical, vision, prescription, dental, and life insurance.
  • 401(k) with a company match.
  • Paid vacation time and paid holidays.
  • Tuition assistance.
  • Opportunities for advancement.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. 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.

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