Quality Specialist

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 passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris could be a great fit for you.

About Us:

At Steris we are the technological leader in design, production, and supply of sterilization test equipment and monitoring systems.

We are currently recruiting for a Quality Specialist vacancy. This is an excellent opportunity to join the business at a skilled professional level and help us maintain and build on the excellent quality standards we commit to.

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

What is 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 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

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.