Job Title:  Quality Specialist

Req ID:  43967
Job Category:  Quality

Bishop's stortford, HEF, GB, cm23 5gz

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.

HOW YOU WILL MAKE A DIFFERENCE

About you:

Do you want to spend your working time making a difference in the world around you? Are you motivated by impactful work? Do you have a passion for Ultrasonic and sonic irrigators and consumables? If so, then a career with STERIS in our Medisafe team could be a great fit for you.

About Us:

At STERIS we are a leading global provider of products and services that support patient care with an emphasis on infection prevention. Our mission is to help our customers create a healthier and safer world. Working at STERIS, you GROWLEARN and MAKE A DIFFERENCE.

We are currently recruiting for a Quality Specialist vacancy. This is an excellent opportunity to join us in a division that drives the business forwards through innovation.

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

What's involved

  • 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.

Required Experience

  • Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485) 
  • Customer complaint investigations
  • Audit coordination
  • CAPA and NCR investigations
  • Risk management
  • Supplier quality and customer assessments
  • Calibration

Equal Opportunities

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by UK employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position.

 

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.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  43967
Job Category:  Quality

Bishop's stortford, HEF, GB, cm23 5gz


Job Segment: Infection Control, Document Control, CAPA, Patient Care, Inspector, Healthcare, Administrative, Management, Quality