Join a growing manufacturing organization where quality is central to every decision and process. This is a key leadership role with the scope to shape and strengthen a robust quality culture, ensuring products consistently meet regulatory standards and customer expectations. You’ll be the driving force behind continuous improvement, audit readiness, and compliance across the business.

About the Role:
As Quality Manager, you will own the development, implementation, and maintenance of the site’s quality management system, ensuring alignment with ISO 9001, cGMP, and material compliance regulations. You will provide strategic direction on quality initiatives, lead the quality team, and act as the primary point of contact for regulatory and customer audits. Your work will directly impact operational efficiency, risk reduction, and customer satisfaction.

Key Responsibilities:

• Lead, maintain, and continuously improve the site’s Quality Management System in alignment with ISO 9001 and cGMP requirements.
• Plan, prepare, and manage internal and external audits, ensuring full audit readiness and timely closure of findings.
• Oversee quality control and assurance activities, including review and approval of quality documentation, procedures, and records.
• Collaborate with cross-functional teams (operations, engineering, supply chain, regulatory) to resolve quality issues and drive corrective and preventive actions.
• Ensure compliance with material regulations such as REACH, RoHS, and TSCA, including documentation, tracking, and reporting.
• Monitor and analyse quality metrics, trends, and nonconformance data to identify improvement opportunities and implement quality initiatives.
• Lead, coach, and develop the quality team, setting clear objectives and fostering a culture of accountability and continuous improvement.
• Prepare and present clear quality reports and updates to site leadership, highlighting risks, progress, and key performance indicators.

Key Requirements:

• Proven experience in a quality management role within a manufacturing or regulated environment.
• Strong knowledge of ISO 9001 and cGMP standards and practical experience implementing and maintaining compliant systems.
• Demonstrated capability in regulatory compliance and audit preparation, with a track record of successful internal and external audits.
• Ability to interpret and apply material compliance regulations (REACH, RoHS, TSCA) in a production or product context.
• Excellent cross-functional communication skills, with the ability to influence and collaborate at all levels of the organisation.
• Strong leadership skills, with experience managing and developing quality teams.
• Advanced documentation and report writing skills, with high attention to detail and accuracy.
• Solid analytical and problem-solving abilities, with a structured approach to root cause analysis and corrective actions.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, Science, or a related technical field.
• Professional certification in quality (e.g., ASQ Certified Quality Engineer, Certified Quality Manager, or equivalent) preferred.
• Formal training in ISO 9001 and/or cGMP requirements.
• Additional training or coursework in regulatory compliance or material regulations (REACH, RoHS, TSCA) advantageous.