Quality Specialist

Steris plc.; Peterlee; On-site; GBP 30,000 - 40,000; Full time

Job summary

A healthcare solutions company in the UK is seeking a Quality Specialist to ensure adherence to various regulatory standards including ISO 9001 and ISO 13485. Responsibilities include managing customer complaints, supporting quality data tracking, and performing document control functions. Ideal candidates will have experience in a regulated industry, strong communication skills, and a customer-first mindset. This role offers the opportunity to contribute significantly to patient safety and product quality.

Qualifications

• Two years experience in a regulated industry (i.e. FDA/ISO 13485).
• Demonstrates a 'Customer first' mindset.
• Collaborates with others in a professional manner.

Responsibilities

• Assist in administration of quality functions to assure adherence to regulatory standards.
• Manage customer complaint investigations and documentation.
• Support supplier quality and customer assessment activities.

Skills

Customer Focus

Teamwork

Detail-oriented

Clear written communication

Ability to analyze technical issues

Tools

Excel

Word

Job description

Quality Specialist – Steris

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, a career with Steris could be a great fit for you.

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.

• Complete document control transactions.
• Manage customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHRs 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.

STERIS strives to be an Equal Opportunity Employer.

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Job Requirements

Key Qualifications

• 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.

A Related Statement from Steris: "STERIS strives to be an Equal Opportunity Employer."