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Quality assurance group lead

Newcastle Upon Tyne (Tyne and Wear)
Medical Engineers Recruitment
Posted: 8h ago
Offer description

Group Quality Leader – Medical Contract Manufacturing

UK (Hybrid)

Full-time | Senior Leadership Role

The Opportunity


We’re partnering with a high-growth Medical Contract Manufacturing Organisation at a pivotal point in its journey. The business is scaling rapidly through acquisition and integration, growing from 3 operating companies to 25 within the next three years.

To support this transformation, we’re seeking a Group Quality Leader to design, implement, and standardise a group-wide Quality Management System, elevate quality capability across multiple sites, and act as a strategic partner to the leadership team.

This is a hands-on, high-impact leadership role with genuine influence across the organisation.


What You’ll Be Responsible For


QMS Strategy & Standardisation


* Designing and implementing a standardised, scalable QMS across all operating companies
* Ensuring compliance with ISO 13485 and integrating aerospace quality standards (AS/EN 9100) as required
* Building a QMS framework capable of supporting rapid growth and acquisition activity


Digital Quality Transformation


* Leading the adoption of electronic / digital QMS platforms
* Driving digital document control, CAPA, change management, training, audit, and non-conformance workflows
* Embedding efficient, modern quality processes across the group


Quality Leadership & Capability Development


* Developing quality capability through clear roles, competencies, and training frameworks
* Mentoring and coaching quality teams across multiple sites
* Establishing group-wide quality metrics, dashboards, and governance routines


Integration & Strategic Projects


* Leading quality integration during acquisitions, including due diligence and gap assessments
* Supporting new facility builds, technology transfers, equipment qualification, and system setup
* Acting as a trusted quality advisor to senior and executive leadership


What We’re Looking For

You’ll be a strong fit if you bring:

* Proven experience designing and implementing QMS at scale
* Deep knowledge of ISO 13485 and medical device manufacturing environments
* Exposure to aerospace or multi-industry quality standards
* Demonstrated success implementing digital / electronic QMS solutions
* A pragmatic, delivery-focused mindset suited to fast-paced, scaling organisations
* The ability to influence, lead, and align stakeholders across multiple sites


Why Join


* A true seat at the table during a major growth and integration phase
* Opportunity to shape quality strategy across a multi-site organisation
* A leadership team that values collaboration, clarity, and fresh thinking
* A mission-driven business improving healthcare outcomes through world-class manufacturing

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