Quality Specialist

STERIS IMS; Leicester; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading healthcare solutions provider in Leicester seeks a Quality Specialist to support ISO compliance, manage customer complaints, and facilitate quality investigations. The ideal candidate will have two years of experience in a regulated industry and strong communication skills. Responsibilities include document control and supporting site inspections. Join a company dedicated to creating a healthier and safer world through innovative healthcare solutions.

Qualifications

• Two years experience in a regulated industry, like FDA/ISO 13485.
• Demonstrates a customer-first mindset with urgency.
• Ability to analyze technical issues and cope with shifting priorities.

Responsibilities

• Complete document control transactions.
• Manage customer complaint investigations and documentation.
• Facilitate CAPA and NCR investigations.

Skills

Customer Focused

Teamwork

Results-oriented

Clear written communication

Technical issue analysis

Tools

Excel

Word

Job 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 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 arethe technological leader indesign, 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.
• Support site inspection activities and recordkeeping.
• 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.

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.