Quality Systems Specialist

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 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 coordinates document control transactions, site record retention, calibration and inspection activities.  In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate.  This role may also track and trend Quality data and support the site Management Review process. This is a day shift position with opportunity to work a hybrid schedule. Position could also include up to 15% travel to facility in Pittsburgh, PA. 

What We Offer You

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 salaries
• Healthcare benefits 
• Tuition assistance
• Paid-time off
• Paid holidays
• Matching 401(k)
• Annual merit increases
• Annual bonus
   

Join us and help write your next chapter.

What You Will Do

• Complete document control transactions.
• Manage Customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Coordinate internal and external audits.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.
   

What Will Help You Be Successful

• Associates' degree required.
• Two (2) years experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
• PC familiarity with MS Office applications including Word, Excel and MS Teams
• Ability to travel up to 15% domestically.

 

#LI-KL1

Skills

• 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.
   

 Pay range for this opportunity is $59,300.00 - $77,826.00. This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.

 

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.

 

Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability.  Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.

 

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,