Job Title:  Senior Quality Specialist (Complaint Handling)

Req ID:  38958
Job Category:  Quality

Rush, NY, US, 1453


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 Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role manages document control transactions, site record retention, calibration, and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaint, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend Quality data and support a site’s Management Review process.

What you will do


  • Manage the document control processes for the site.
  • Lead Customer complaint investigations and ensure complete complaint documentation.
  • Lead CAPA and NCR investigations and ensure proper documentation.
  • Manage the DHR and batch record release process.
  • Manage record retention practices within the site.
  • Coordinate site calibration activities and recordkeeping.
  • Manage site audit activities and recordkeeping.
  • Support Support supplier quality and Customer assessment activities.
  • Track, trend and analyze Quality data.
  • Support targeted Lean activities.
  • Complete other duties as assigned. 

What you will need to be successful


  • Bachelor’s Degree (Engineering/Scientific)
  • 5+ of experience in a regulated industry (i.e., FDA/ISO 13485)
  • Bachelor’s degree required in related technical field (i.e., Engineering, Chemistry, Biology).
  • Certification: ASQ, QSR, or AAMI certification preferred.
  • Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)
  • Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
  • Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
  • Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
  • Communication: Constructs clear written communication. Keeps manager and co-workers informed.
  • Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
  • Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
  • Understands and can interpret appropriate regulatory standards.
  • Ability to analyze and interpret data and use as input to problem solving.

What we offer


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 pay
  • Annual merit bonus and incentive plans
  • Medical, vision, prescription, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • Tuition assistance
  • Opportunities for advancement
  • Friday, team rotation, work from home


Join us and help write our next chapter.




 Pay range for this opportunity is $59,300.00 - $77,826.00.


Minimum pay rates offered will comply with county/city minimums, if higher than range listed.  Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.


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:  38958
Job Category:  Quality

Rush, NY, US, 1453

Job Segment: Document Control, Infection Control, Inspector, Engineer, CAPA, Administrative, Healthcare, Engineering, Management, Quality