Principal Quality Associate

GBUK Group; United Kingdom; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading medical device company is seeking a Principal Quality Associate to join their Quality team in Bicester. This senior role requires strong experience in quality roles, particularly within the Medical Device industry. You will be responsible for ensuring compliance with standards and collaborating closely with manufacturing and suppliers. Key tasks include supporting audits, managing non-conformities, and implementing quality processes. Additionally, a proactive approach and strong communication skills are essential for success in this influential position.

Benefits

Opportunity to impact quality across a growing organization

Collaboration with leadership and suppliers

Focus on practical quality improvements

Qualifications

• Experience in a quality role within the Medical Device industry.
• Strong knowledge of recognized quality management systems.
• Hands-on experience with CAPA and root cause analysis.

Responsibilities

• Support incoming inspection and goods release activities.
• Investigate product non-conformities and drive CAPA.
• Maintain compliant quality processes aligned to regulations.
• Conduct internal and supplier audits.

Skills

Quality role experience in Medical Device industry

Knowledge of QMS (ISO 13485 or ISO 9001)

CAPA and root cause analysis

Process compliance writing

Attention to detail

Strong communication skills

Proactive problem-solving

Knowledge of MDR

Knowledge of FDA incident reporting

Job description

We’re looking for an experienced Principal Quality Associate to join our Quality team at our Bicester site, playing a key role in maintaining and strengthening quality and compliance across the business.

Reporting to the Compliance Director, you’ll work closely with Quality Control, Manufacturing and Suppliers to ensure products meet regulatory and customer requirements — from incoming inspection through to goods release, audits, and corrective actions.

This is a hands‑on, influential role for someone who thrives in a regulated environment and enjoys turning quality requirements into practical, compliant processes.

What You’ll Be Responsible For

• Supporting incoming inspection and goods release activities in collaboration with the Quality Control team
• Investigating product non-conformities and driving effective corrective and preventive actions (CAPA)
• Developing, implementing and maintaining compliant quality processes aligned to regulatory standards
• Planning, conducting and completing internal audits and supplier audits
• Supporting external audits, including preparation of documentation and participation during assessments
• Logging, investigating and documenting non-conformities (NCs) and CAPAs, ensuring timely resolution
• Monitoring and maintaining goods‑in quality metrics, preparing data for quality and management reviews
• Conducting supplier evaluations and supporting supplier compliance meetings with relevant data and insights
• Coordinating Quality Control tasks to ensure product holds are resolved efficiently and compliantly
• Supporting quality activities at GBUK acquisition sites
• Undertaking additional quality-related tasks as required by the Head of Quality or Compliance Director

What We’re Looking For

• Experience working in a Quality role within the Medical Device industry
• Strong working knowledge of a recognised QMS (ISO 13485 or ISO 9001 as a minimum)
• Hands‑on experience with CAPA, non‑conformities and root cause analysis
• Experience writing and implementing processes compliant with standards
• Excellent attention to detail with a structured, methodical approach
• Strong communication skills and the ability to work effectively across teams
• A proactive, problem‑solving mindset with the ability to manage multiple priorities
• Knowledge and experience of MDR
• Experience or knowledge of FDA incident reporting

Why Join Us?

• A senior, influential quality role with real impact
• Close collaboration with manufacturing, suppliers and leadership
• A business that values practical quality, not just paperwork
• Opportunity to support quality across a growing organisation

Important

👉 Candidates must be based in or able to commute to the Bicester area.