Supplier Quality Engineer

The Supplier Quality Engineer 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.  This role 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'll do as a Supplier Quality Engineer:

• 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 procedures 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. 

• 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. 
• Perform quality system audits and provide guidance on corrective actions.
• Perform other duties as assigned.

The Experience, Skills and Abilities Needed:

• 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

Preferred Experience

• 1-5 years of experience with medical device or other regulated industries preferred
• ASQ, QSR or familiarity with QSR/GMP regulations preferred
• Experience with statistical analysis software and Visio preferred.

What STERIS Offers:

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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