Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They are a joint venture between two major global healthcare and consumer goods companies, and their flagship brand is recognised the world over as providing accurate home pregnancy and fertility monitoring tests. Are you an ISO 13485 Quality Professional looking for a challenging opportunity to drive Quality improvement in an External Manufacturing environment? If so, this could be a great position to explore. Our client is looking for a Quality Operations Manager to join their Quality team on a Full-Time, Permanent basis. The role will be based at their Innovation Centre in Bedford, UK with option for Hybrid Working. This is an excellent opportunity for an experienced Quality professional to take a leading role in ensuring compliance and driving quality excellence across global manufacturing and distribution partners. The role will involve both strategic oversight and hands-on management of Quality operations to support life cycle management of base business and new product introductions (NPI). Our client is looking for someone who is highly organised, detail-oriented, and passionate about maintaining the highest standards of product quality and compliance. Applicants will have the ability to collaborate effectively across organisational boundaries and influence a wide range of stakeholders, both internally and externally. The role holder will be expected to represent the company to the highest professional standards, so strong leadership, interpersonal skills, and excellent written and oral communication skills are essential. The successful candidate will be results-focussed, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers. Previous experience in leading Quality assurance for medical devices or IVDs is essential, along with a deep understanding of ISO 13485 and other international standards. The successful candidate will have demonstrated success in managing Quality relationships with External Manufacturing and distribution partners and will be confident in leading audits and inspections, with a willingness to travel. A high level of IT literacy is required, and familiarity with ISO 14971, FDA 21 CFR Part 820, MDSAP, and IVDR would be advantageous. Our client can offer you: Hybrid working. 25 days paid annual leave plus bank holidays (pro-rata). Company pension scheme including competitive employer's contribution. Private Medical Insurance package with additional medical cash plan scheme. Enhanced maternity and paternity pay. Company supported employee Health and Wellbeing programme. Life assurance. Free electrical car charging points. Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail). If you require any reasonable adjustments to support you, at any stage during the application process, just let our client know how they can help. Our client is an equal opportunity employer and values diversity. They do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status. The Company Our client is a world leader in the research, design and marketing of advanced consumer diagnostic products, operating as a joint venture between two major global organisations. Their research centre is at the cutting edge of innovation, fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. They are committed to answering the needs of existing and future consumers, through a continuous flow of new and innovative products. Interested? Click apply and you will be redirected to our client’s careers page to complete your application.