Quality Specialist

12 hours ago

Leicester, United Kingdom STERIS Full time

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 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

**Equal Opportunities**:
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.

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