- Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
- Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
- Leads process and product corrective actions and problem-solving activities.
- Reviews the current quality system and recommend / implement improvements as needed.
- Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
- Leads projects focused on quality system, product quality and service quality improvements.
- Develops analyses and reports on the performance of the quality system.
- Leads supplier audits and corrective actions.
- Leads and supports internal and external quality system audits.
- Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborates with other departments and facilities within the company on quality related issues.
- Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
- Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
- Perform all other duties as assigned.
- Bachelor's Degree in Engineering or related technical field.
- 6-10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 6-10 years of experience working in an ISO certified environment.
- 6-10 years of experience with medical device or other regulated industries.
- ASQ, QSR or familiarity with QSR/GMP regulations.
- Experience with statistical analysis software and Visio .
- 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.
- This is an onsite position based in Plymouth, MN.
- The schedule is: M-F, dayshift hours.
- 10-20% domestic travel.
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Senior Quality Engineer - Plymouth, United States - STERIS
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 Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
Duties
Duties - cont'd
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Required Experience
Preferred Experience
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Skills
Work Schedule
Safety Sensitive Position
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.
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.
