QA/RA Manager in Stockport

A brand new opportunity for a QA/RA Manager to join a rapidly growing medical device supplier based near Stockport, taking full ownership for the implementation and improvement of QA/RA and QMS gap analysis. This is a newly created position and an exceptional opportunity to play a pivotal role in shaping the future of a fast-growing organisation that supplies clinics and healthcare providers across the UK and Europe.

As part of a high-performance, outcome-driven environment, you will be responsible for all Regulatory Affairs and QA / QMS matters not only at the company's UK facility, but also supporting suppliers and partners based in mainland Europe. Flexible working arrangements, generous benefits, and ongoing training opportunities are available to support your professional growth, with the position offering a starting salary of between £55,000 and £65,000 p/a alongside additional benefits.

What you’ll do:

• Oversee the critical functions that underpin the organisation's commitment to operational excellence.
• Maintain internationally recognised certifications while proactively monitoring regulatory landscapes across the UK and EU.
• Champion audit readiness by ensuring documentation is always current and accessible for both internal reviews and external inspections.
• Foster an open culture of accountability around quality and safety standards, collaborating closely with colleagues from teams including procurement, operations, HR, IT and customer experience to resolve issues swiftly through structured CAPA processes.
• Drive supplier qualification efforts so that every product meets rigorous standards before reaching customers.
• Lead strategic projects focused on digitising compliance workflows while supporting broader ESG initiatives.
• Maintain ISO certifications (9001/14001) while continuously improving quality management systems to meet evolving regulatory requirements.
• Lead audit readiness activities across the business in both the UK and EU, ensuring documentation is accurate and up-to-date for internal and external audits.
• Monitor emerging legislation, industry standards, and regulatory changes; communicate impacts effectively to senior leadership teams.
• Foster a culture of quality, compliance, and safety with accountability and openness throughout all departments by developing robust frameworks.
• Collaborate cross-functionally to manage corrective actions including resolving customer complaints and root-cause issues through effective CAPA processes.
• Manage technical documentation including post-market surveillance activities such as recalls, vigilance reporting of adverse incidents to authorities, and communication with distributors.
• Qualify, monitor, and audit suppliers as well as contract manufacturers to ensure incoming products consistently meet stringent quality standards.
• Lead projects aimed at digitising compliance processes while supporting change management initiatives that align with new legislation or business needs.

What you bring:

• Proven experience in a leadership role within QA/RA functions - ideally gained in medical device or healthcare product supply chains.
• Comprehensive working knowledge of MDR 2017/745 regulations alongside ISO 9001 and ISO 14001 standards for quality management systems.
• Analytical mindset with a data-driven approach to decision making; proficiency in Excel for tracking metrics and generating reports.
• Exceptional communication skills enabling you to engage stakeholders at all levels while influencing cross-functional teams towards shared goals.
• Experience leading change management initiatives within complex organisations undergoing rapid growth or transformation.
• Self-motivated with excellent organisational skills; able to work independently with minimal supervision while prioritising competing demands effectively.

Desirable:

• Working knowledge of ISO 13485 standard for medical devices would be advantageous but not essential for success in this role.
• Prior experience acting as PRRC (Person Responsible for Regulatory Compliance) or EU RP within regulated environments is highly valued.
• Experience scoping or implementing e-QMS software solutions.

What sets this company apart:

This organisation stands out due to its unique blend of entrepreneurial agility backed by significant investment, enabling rapid expansion across both UK fulfilment centres and European warehouses. Operating within a high-performance SME culture built on customer focus, teamwork powered by shared ownership, honesty in communication, and outcome-driven results means every employee's contribution truly matters here. The company thrives on challenge rather than comfort; those who succeed are hands-on problem solvers who value accountability just as much as adaptability.

You will find yourself surrounded by colleagues who enjoy building systems rather than simply maintaining them - resilience is celebrated alongside ambition. With integrated systems like WMS SAP Business One supporting scalable operations plus ongoing investment into digital transformation projects (including e-QMS), there are ample opportunities for personal growth through tackling problems together.

What’s next:

If you are experienced in QA/RA implementation and improvement and looking to advance your career then this position is definitely worth exploring further - apply now using the link provided.