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    Quality Engineer - Minneapolis, United States - STERIS

    STERIS
    STERIS Minneapolis, United States

    3 weeks ago

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    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.

    The Role

    The Quality Engineer (Supplier) in our Plymouth manufacturing location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards.

    The Quality Engineer supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

    What You Will Do

    • Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
    • Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
    • Initiate and/or participate in process and product corrective actions and problem-solving activities.
    • Update/establish documented work instructions as needed.
    • Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
    • Monitor and report on performance metrics.
    • Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
    What You Will Also Do
    • Collaborate with other departments and facilities within the company on quality related issues.
    • Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
    • Support Customer and regulatory audits.
    • Perform supplier audits and provide guidance on corrective actions.
    What You Will Need to Be Successful
    • Bachelor's Degree in Engineering or related technical field, required.
    • 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
    • 1-5 years of experience working in an ISO certified environment required.
    • 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.
    • Ability to travel up to 10 %
    Preferred Experience
    • 1-5 years of experience with medical device or other regulated industries, preferred.
    • Experience with Supplier Quality, strongly preferred.
    • ASQ, QSR or familiarity with QSR/GMP regulations, preferred.
    • Experience with SAP or Oracle, preferred.
    • Experience with ISO13485 strongly preferred.
    • Strong experience with Quality Management Systems (QMS), preferred.
    • Experience with Data Analytics, preferred.
    Safety Sensitive Position

    What STERIS Will Offer You

    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.

    #LI-MO1

    STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

    If you need assistance completing the application process, please call 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 § 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.

    Req ID: 42678

    Job Category: Quality
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