Head of Quality in Coleraine

WHY JOIN US? We’re good at what we do – come and join us and you can benefit from:

• Blended Working
• Bonus
• 25 days holiday plus bank holidays (rising to 28)
• Option to buy holiday days
• Wellbeing Programme
• Health Cash Plan
• Pension
• Life Assurance
• Enhanced Maternity/Paternity
• Cycle to Work Scheme
• Referral Scheme
• Long Service Awards
• Free Parking

This role will primarily be based at one of our core manufacturing sites in either Cardiff (UK), Comber (NI) or Coleraine (NI) with optional hybrid working.

ABOUT THE ROLE

Reporting to the Director of Compliance, the Head of Quality is responsible for the design, development, and implementation of the Quality Strategic Plan. This includes maintaining ISO 13485 certification and ensuring the smooth and efficient operation of all Quality related activities across the company’s multi-site operation. This role provides an effective quality and regulatory interface, ensuring that the Quality Management System (QMS) and product lifecycle controls support compliance across key markets. It also supports external regulatory interactions with Notified Bodies and strengthens audit readiness through robust documentation, governance, and cross-functional collaboration.

KEY RESPONSIBILITIES

• Develop the Quality Strategy annually and translate it into a rolling multi-year functional plan aligned to business needs, with clear ownership, timelines, and measures.
• Build, embed and sustain a progressive quality culture across all sites.
• Define and implement meaningful KPIs that drive right-first-time performance, accountability and continual improvement.
• Lead, coach, and develop high-performing QA/QC teams across sites using robust performance management, capability development, and succession planning.
• Own the quality training plan across the group, ensuring appropriate competence frameworks, role-based learning, training effectiveness, and sustained compliance with QMS and regulatory requirements.
• Own and lead QMS governance and operational excellence.
• Ensure policies, procedures and practices are consistently implemented, effective and fit for purpose across all sites including harmonised QA/QC standards and raw material specifications.
• Maintain robust governance for key QMS processes, with particular focus in change control and CAPA, ensuring timely, risk-based decision making and sustained effectiveness.
• Champion continuous improvement across operations, embedding process capability and quality by design principles to deliver measurable improvements in efficiency, right first-time performance, and customer outcomes.
• Partner proactively with Engineering, Operations, and R&D to ensure new processes, systems and assets are compliant by design, effectively validated and successfully embedded.
• Ensure all sites maintain a constant state of audit readiness, with clear ownership, robust evidence, and structured plans in place for both announced and unannounced audits.
• Lead internal audit planning and execution (directly and through the team), ensuring strong root cause analysis and timely CAPA closure and the effective ongoing monitoring of actions.
• Act as the primary quality contact for external audits and inspections including Notified Body and customer audits, ensuring effective preparation, professional conduct, and strong post-audit follow-up.

Regulatory Interface & Compliance Leadership

• Partner with cross-functional stakeholders to ensure Quality strategy and QMS controls enable compliance with applicable regulatory requirements across products and markets, escalating enterprise-level compliance risk where needed.
• Collaborate closely with cross functional teams to ensure technical documentation and lifecycle evidence remain inspection ready throughout the product lifecycle.
• Coordinate product and process change activities to protect ongoing compliance and regulatory approvals/registrations across global markets.
• Build and maintain effective working relationships with external parties including Notified Bodies and key service providers.
• Where quality intersects with product safety and lifecycle compliance, work in close partnership with the Regulatory function, demonstrating strong regulatory awareness and mindset.
• Build strong, trusted relationships with therapeutic area leadership teams, group operations and enabling functions to deliver business goals while minimising compliance exposure.
• Liaise with Finance to provide accurate quality KPI reporting on a monthly, quarterly, annual basis, supporting effective governance and decision making.
• Coordinate and chair organisation-wide management review process at ELT level, ensuring effective review of QMS performance and regulatory compliance risks.

Other

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s Health and Safety policy.
• To adhere to the company’s Quality policy and Environmental policy.
• To undertake other duties as may be reasonably required.

WHAT WE’RE LOOKING FOR

Essential

• Senior quality leadership experience in a regulated medical device (or similarly regulated) environment, ideally across multiple sites.
• Strong leadership, stakeholder management, and communication skills (written and verbal).
• Knowledge of MDSAP.
• Demonstrable experience running an effective QMS, driving audit readiness, CAPA effectiveness, and continuous improvement.
• Comfortable operating with ambiguity, prioritising effectively, and challenging the status quo with practical solutions.
• Working knowledge of key medical device regulatory frameworks and expectations, especially where they intersect with QMS and lifecycle controls (Notified Body expectations, post-market inputs, change control).

Desirable

• Internal and external Auditor certification.
• CI experience.
• Experience partnering closely with Regulatory Affairs teams and/or leading combined quality–regulatory initiatives.
• Experience in MDSAP environment.

ADDITIONAL INFORMATION

• People leadership responsibilities (multi-site direct reports).
• Control of budgets and equipment.
• Multi-site remit with regular travel to core sites (including overnight stays as required).

COMPETENCIES

• Business Insight: Applying knowledge of business and the marketplace to advance the organization’s goals.
• Balances Stakeholders: Anticipating and balancing the needs of multiple stakeholders.
• Optimizes Work Processes: Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Builds Networks: Effectively building formal and informal relationship networks inside and outside the organization.
• Organizational Savvy: Manoeuvring comfortably through complex policy, process, and people-related organizational dynamics.
• Persuades: Using compelling arguments to gain the support and commitment of others.
• Courage: Stepping up to address difficult issues, saying what needs to be said.
• Manages Ambiguity: Operating effectively, even when things are not certain, or the way forward is not clear.

The closing date for applications is: 13th March 2026. If we receive a high volume of applications, we may close this role earlier than planned.