BioTalent
Quality Assurance Manager
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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.
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About You
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Your very own career expert that helps elevate your application to the next level.
- 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.
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