Principal Quality Associate

GBUK Group; Bicester; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading provider of medical devices is seeking a Senior Quality & Regulatory Associate to support Quality and Regulatory activities in Bicester. The role involves developing processes that meet standards, conducting audits, and managing non-conformities. Essential qualifications include experience in the medical device industry, familiarity with ISO standards, and auditing experience. Join a growing organization where your contributions impact patient care and device safety.

Benefits

Professional development opportunities

Cross-functional collaboration

Meaningful contribution to patient care

Qualifications

• Experience in a Quality environment within the Medical Device industry.
• Minimum experience with recognised QMS: ISO 13485 or ISO 9001.
• Lead Auditor level experience in internal auditing.

Responsibilities

• Develop and implement processes meeting standards and regulations.
• Plan and complete internal and external supplier audits.
• Prepare documentation for and assist with external audits.

Skills

Quality control experience

Knowledge of ISO 13485 or ISO 9001

Internal auditing experience

CAPA and Root Cause Analysis

Process writing compliance

Job description

GBUK Group is a leading provider of specialist medical devices, trusted by healthcare professionals across the UK and internationally. We are expanding our team and seeking a Senior Quality & Regulatory Associate to support and enhance our Quality and Regulatory activities across our Bicester and Newbury sites.

About the Role

Reporting to the Compliance Director, this key role is responsible for working with the quality control team and supporting all of the tasks required for incoming inspection and goods release; for investigating product non-conformities and implementing effective corrective actions; assisting in assuring company compliance to the relevant standards and regulations and implementing compliant processes and for working with the manufacturing department to facilitate quality responsibilities.

Key Responsibilities

• Develop and implement efficient processes that meet applicable standards and regulatory requirement
• Plan, initiate and complete internal and external supplier audits
• Support external audits by preparing documentation and assisting during assessments
• Manage the logging, investigation, and document non-conformities ensuring timely resolutions including CAPA's (Corrective and Preventative Action Reports) and NC's (Non-Conformity Reports
• Monitor and maintain goods-in metrics, preparing relevant data for quality and management review meetings
• Conduct supplier evaluations to ensure ongoing compliance with quality standards
• Support supplier compliance meetings by providing relevant data and insights
• Coordinate tasks for the Quality Control team, ensuring timely resolution of product holds while maintaining compliance
• Support quality control at GBUK acquisition sites

Essential Experience and Skills

• Experience of working in a Quality environment within the Medical Device industry
• Experience of working to a recognised QMS: ISO 13485 or ISO 9001 as a minimum
• Experience in internal auditing, preferably at Lead Auditor level
• Experience of CAPA and Root Cause Analysis
• Experience in writing processes compliant with standards

Desirable Experience

• Knowledge or experience of MDR requirements
• Experience or knowledge of reporting incidents to the FDA
• Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company.
• Good organisation and leadership skills with attention to detail. A can-do attitude with the ability to take initiative and work to deadlines across multiple simultaneous tasks and projects.
• Problem solver

Why Join GBUK Group?

You will be part of a growing, purpose-led organisation where your work directly impacts patient care and device safety. The role offers opportunities for professional development, cross-functional collaboration, and meaningful contribution to the future of GBUK’s medical device portfolio.

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.