Job Title:  Senior Quality Engineer

Req ID:  38450
Job Category:  Quality

Birmingham, AL, US, 35222


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.


• 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

Required Experience

Bachelors Degree required preferably in Engineering or Technology related

ASQ, QSR, or AAMI certification ideal

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 working on 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 leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers 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:  38450
Job Category:  Quality

Birmingham, AL, US, 35222

Nearest Major Market: Birmingham

Job Segment: Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Manufacturing Engineer, Engineering, Quality