Job Title:  Quality Engineer - Plymouth, MN

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.

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