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Title:  Senior Quality Engineer

Req ID:  15004
Category:  Quality
City:  Mentor
State:  OH
Postal Code:  44060
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 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 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 plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Duties

  1. Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer. 
  2. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. 
  3. Lead and/or participate in process and product corrective actions and problem-solving activities. 
  4. Constantly review the current quality system and recommend / implement improvements as needed. 
  5. Review collected data to perform statistical analysis and recommend process / product changes to improve quality.
  6. Lead projects focused on to quality system, product quality and service quality improvement. 
  7. Report on the performance of the quality system. 
  8. Participate in strategic planning and audits of internal and supplier quality systems. 
  9. Participate/support external and internal quality system audits.
  10. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. 
  11. Collaborate with other departments and facilities within the company on quality related issues. 
  12. Supervise Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
  13. Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials. 
  14. Perform all other duties as assigned. 

Degree Requirements

Bachelor's Degree in Engineering or related technical field

Required Experience

  1. 6-10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
  2. 6-10 years of experience with medical device or other regulated industries preferred.
  3. 6-10 years of experience working in an ISO certified environment required.
  4. ASQ, QSR or familiarity with QSR/GMP regulations preferred.

Skills/Competencies

  1. Excellent problem-solving skills
  2. Focus on identification of potential issues and continuous improvement.
  3. Experience working on cross-functional teams and on own initiative.
  4. Demonstrated excellent organizational, oral and written communications skills.
  5. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
  6. Experience with statistical analysis software and Visio preferred.

 

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.

The full affirmative action program, absent the data metrics required by § 60-741.44(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.

Req ID:  15004
Category:  Quality
City:  Mentor
State:  OH
Postal Code:  44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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