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Title:  Senior Quality Engineer

Req ID:  11347
Category:  Quality
City:  St. Louis
State:  MO
Postal Code:  63133
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 position is responsible for developing, maintaining and improving the quality system in accordance with the requirements of ISO, FDA QSR and STERIS policies.   This would include but is not limited to: quality planning in support of new product development, product quality improvement, complaint and CAPA management, supplier quality management, production and process controls, and continuous improvement through the use of statistical techniques and other accepted quality practices. This position plans and directs activities concerned with development, implementation, maintenance, and continuous improvement of our quality system.

Duties

  • Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer. 
  • 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. 
  • Constantly review the current quality system and recommend / implement improvements as needed. 
  • Review collected data to perform statistical analysis and recommend process / product changes to improve quality. 
  • Report on the performance of the quality system. 
  • Participate in strategic planning and audits of internal and supplier quality systems. 
  • Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. 
  • Interface with various 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 all other duties as assigned. 

Education Requirement

Engineering or Technology related Bachelors Degree required. ASQ, QSR, or AAMI certification preferred.

Required Experience

  • 6-10 years combined Manufacturing Engineering and/or Quality Systems experience with a focus on Design Control and CAPA. Advanced degrees or Quality Certifications are also desirable:  CQE, CQA, CQMgr., Six Sigma or Lean. 
  • Medical Device or other regulated industry experience required. 
  • Familiarity with QSR/GMP regulations desired. 
  • Process Validation experience desired. 
  • Excellent problem solving skills. 
  • Experience leading cross-functional teams. 
  • 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. 
  • Experience with statistical analysis software desired. 

 

STERIS is a $2B+, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. 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.

Req ID:  11347
Category:  Quality
City:  St. Louis
State:  MO
Postal Code:  63133


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