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.

What You’ll do as a Quality Systems Specialist

• 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

The Experience, Skills, and Abilities Needed

Required:

• Associate degree (Engineering / Scientific)
• Minimum 2 years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485)
• Minimum 2 years of experience in a regulated industry (i.e. FDA/ISO 13485)

 

Other:

• Customer Focused: Demonstrates a “Customer first” mindset.  Responds with a sense of urgency
• Teamwork: Collaborates with others and works in a professional manner to support team actions
• Results: Effectively manages work tasks, is detail oriented and strives for continuous improvement, has the ability to analyze technical issues and to cope with change and shifting priorities
• Communication: Constructs clear written communication and keeps report to manager and co-workers informed
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word

 

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

 

Here is a brief overview of what we offer:

 

• Market competitive pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits
• Long/short term disability coverage
• 401(K) with company match
• Maternity and parental leave
• Additional add on benefits/discounts for programs such as pet insurance
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career

 

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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 a