Senior Quality Lead – Medical Devices & Compliance

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

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.