Quality Assurance Manager

BioTalent; East Midlands; On-site; GBP 65,000 - 90,000; Full time

Job summary

BioTalent is seeking a hands-on Quality Manager for a growing medical device manufacturer in the East Midlands. You will be the senior quality presence on site, working closely with Production, Engineering and Supply Chain to ensure first-time-right quality and swift resolution of issues.

You will drive product quality, lead investigations, support customers and nurture a strong quality culture on the shop floor and in regulatory environments, including ISO 13485.

Qualifications

• Experience as Quality Manager or similar in medical device manufacturing.
• Strong background in CAPA and RCCA processes.
• Experience with ISO 13485.
• Ability to lead cross-functional teams on the shop floor.

Responsibilities

• Act as senior quality representative across manufacturing operations.
• Lead investigations into complaints and non-conformances.
• Drive RCCA and CAPA actions with cross-functional teams.
• Develop and coach site quality personnel and drive continuous improvement.
• Support customer quality discussions and audits.

Skills

Quality leadership

CAPA & RCCA

Root cause investigations

Stakeholder management

On-site manufacturing

People management

Job description

We are supporting a growing manufacturer operating within a regulated medical device environment to appoint a hands-on Quality Manager.

This position will suit an individual who enjoys being close to manufacturing operations and is comfortable acting as the senior quality presence on site. Rather than focusing purely on quality systems administration, the successful candidate will work closely with Production, Engineering and Supply Chain teams to ensure products are manufactured right first time and quality issues are resolved effectively.

You will play a key role in driving product quality, leading investigations, supporting customers and developing the site's quality culture.

Key Responsibilities

• Act as the senior quality representative across manufacturing operations.
• Support production teams in maintaining high standards of product quality and process compliance.
• Lead investigations into customer complaints, non-conformances and manufacturing issues.
• Drive RCCA activities with cross-functional teams to identify root causes and implement sustainable corrective actions.
• Provide quality leadership within cleanroom and controlled manufacturing environments.
• Partner with Engineering and Operations teams to improve manufacturing performance and reduce quality defects.
• Support supplier quality activities and manage quality concerns impacting production.
• Lead customer quality discussions, complaint reviews and audit activities.
• Develop, coach and manage site quality personnel.
• Drive continuous improvement initiatives across manufacturing processes and product quality.

About You

• Experience in a Quality Manager, Site Quality Manager, Manufacturing Quality Manager or Head of Quality position.
• Strong background within medical device manufacturing.
• Working knowledge of ISO 13485.
• Experience supporting manufacturing operations involving components, assemblies or plastic products.
• Proven track record leading complaint investigations, CAPA and RCCA activities.
• Comfortable operating on the manufacturing floor and influencing production teams.
• Previous people management and team development experience.
• Strong customer-facing and stakeholder management skills