Quality Assurance Manager /Medical Devices - Maternity Cover

Quality Assurance Manager / Medical Devices - Maternity CoverJoin to apply for the

Quality Assurance Manager / Medical Devices - Maternity Cover

role at

Vision RT Ltd .

About Vision RTVision RT

is a rapidly growing MedTech which is transforming radiation therapy for cancer patients, helping to make it more accurate, effective and comfortable. We are the inventors of, and the market leaders in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, for more guidance across every step of the radiotherapy workflow.

Our SGRT solutions are used in 24 out of the 25 “Best Hospitals for Cancer,” as tracked by US News and World Report.

We’re one of Britain’s fastest-growing private tech companies, as recently recognised by the 2025 Sunday Times 100 Tech list. We’re also the proud winners of a 2024 King’s Award for Enterprise, the UK’s most prestigious accolade for business excellence.

Company video

With around 300 employees globally, and offices in the UK, Poland and the USA, Vision RT operates independently as part of the Danish company William Demant Invest A/S - one of the world’s largest investors in healthcare companies. Vision RT staff members have the security and reach that comes with being part of a large global enterprise, combined with the freedom and agility of a startup.

This is a company with strong values, a clear mission and a bright future. It’s an exciting and rewarding place to work.

About the roleThe Quality Manager sits within the Quality, Regulatory and Compliance Team and will act as line manager for the Complaints, Management Systems, Supplier Quality and Process Engineering Teams, supporting eight direct reports with quality processes surrounding the manufacture and life cycle of medical devices.

You will play a critical role in ensuring compliance is maintained and quality issues are prioritised using a risk-based approach, which will include collaborating with other entities within the firm to gather additional information and gain full understanding of problems, with support from other managers from the surrounding teams.

Key responsibilities

Act as line manager for the Complaints Team, supporting escalation of issues / trends, timely processing of complaints.

Act as a line manager for the Management Systems Team, supporting Internal audits, NCR / CAPA, Document Control.

Act as a line manager for the Supplier Quality Team, supporting Supplier control – (ASL, SCARs, Supplier Audits, Supplier Approvals and Reviews), Non-conforming Product, Device History Records (DHR), Goods Inwards (incl. inspection processes).

Act as a line manager for the Process Engineering Team, supporting Change management and DMR maintenance, Production Failure Mode Effect Analysis, Production transfer validation (IQ, PQ, OQ).

Act as dotted-line manager / support for the Returns, for the purpose of collecting, analysing and acting on quality data.

Act as a Manager with Executive Responsibility for Quality and Post-Market Surveillance within the QMS.

Support the Person Responsible for Regulatory Compliance (PRRC) under the EU MDR 2017/745 and in their responsibilities in the areas of checking conformity of the device before release, adverse event reporting and post-market surveillance. Deputise for the PRRC in their absence.

Represent Vision RT with external stakeholders (e.g. notified body, regulators, suppliers, distributors, customers) for areas of responsibility.

Act as an internal and supplier auditor to applicable quality management requirements.

Other duties in support of the company’s quality policy and objectives.

This role requires occasional UK and international travel.

Degree or equivalent qualification in product-based engineering.

Minimum 2 years of leadership experience.

Minimum 5 years’ experience in a Quality Assurance role in medical devices or electronic products.

Minimum 5 years’ experience of working with standards and regulations applicable to medical device quality management systems, e.g. ISO 13485, 21 CFR parts 803, 806, 820, EU MDR 2017/745 and/or the Medical Device Single Audit Program.

Strong organizational skills, and ability to manage teams.

Excellent verbal and written communication, technical writing, critical thinking and presentation skills.

Critical thinking and attention to detail, as well as a demonstrable level of evidence-based approach to data review and root-cause analysis.

Ability to work and interact effectively and professionally with others throughout various levels of the global organization.

Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.

Fluent in written and spoken English.

Equal OpportunityVision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.

LocationBasingstoke, England, United Kingdom

Seniority levelMid-Senior level

Employment typeContract

Job functionManagement and Quality Assurance

IndustriesComputers and Electronics Manufacturing and Technology, Information and ..... full job details .....