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Quality Engineer

Date: 28-Nov-2018

Location: Derby, DBY, GB, DE21 6LY

Company: Steris Corporation

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

Quality Engineer will be responsible for developing, maintaining and improving 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.  This role will also strive to improve Supplier Quality standards and process, as well as supporting complaint/CAPA investigations, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles 

Based in Derby with some travel required.

Duties

Primary duties will include (but not limited to;

  1. Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance. 
  2. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. 
  3. Initiate and/or participate in process and product corrective actions and problem-solving activities. 
  4. Update/establish documented procedures as needed. 
  5. Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
  6. Monitor and report on performance metrics. 

Required Experience

Background

Ideally degree educated with excellent knowledge of Quality Engineer or Systems within a Manufacturing environment.

Experience in medical device or other regulated industry preferred. 
Experience working in an ISO certified environment required. 
Familiarity with QSR/GMP regulations preferred. 
Excellent problem-solving skills. 
Experience working on cross-functional teams

 

STERIS plc is a $2B+, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.

STERIS strives to be an Equal Opportunity Employer.