Quality Specialist

STERIS; Hoddesdon; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading global provider in healthcare seeks a Quality Specialist dedicated to ensuring patient safety through compliance with regulatory standards. This role focuses on managing quality data, supporting investigations, and facilitating audits, making a significant impact on patient care quality.

Qualifications

• Two years experience in a regulated industry (FDA/ISO 13485).
• Experience in audit coordination and customer assessments.
• Experience in CAPA and NCR investigations.

Responsibilities

• Manage customer complaint investigations and documentation.
• Coordinate internal and external audits.
• Support supplier quality and customer assessment activities.

Skills

Customer complaint investigations

Audit coordination

CAPA and NCR investigations

Supplier quality

Calibration

Job description

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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

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical industries? Do you care about keeping patients and people safe? If so, then a career with Steris could be a great fit for you.

At STERIS we are the trusted experts and global leaders inmedical device repairservices and surgical instrument manufacturing

We are dedicated to enabling patient safety and driving improvements in quality outcomes and efficiency across all our products and services and currently recruiting for Quality Specialist

What's involved

• 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 (. FDA/ISO 13485)
• Customer complaint investigations
• Audit coordination
• CAPA and NCR investigations
• Supplier quality and customer assessments
• Calibration

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.