Role Purpose
The Quality Manager leads the effective operation, maintenance and continual improvement of ActivInsights’ Quality Management System (QMS), ensuring that products, services and business processes meet applicable regulatory, quality and customer requirements.
Reporting to the Regulatory Affairs Manager, the role owns the day-to-day management of the QMS and provides quality leadership across the business. The Quality Manager escalates significant quality and compliance risks and supports regulatory strategy, technical documentation, inspections and certification activities while maintaining clear accountability between Quality and Regulatory Affairs.
Responsibilities
QMS Leadership & Governance
- Lead the operation, maintenance and continual improvement of the QMS in accordance with ISO 13485:2016, the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, and other applicable requirements.
- Coordinate management review, prepare QMS performance information and analyse quality metrics, trends and risks to support effective decision-making.
- Support the continued development and effective use of the electronic Quality Management System (eQMS).
- Monitor relevant quality standards and regulatory developments, working with the Regulatory Affairs Manager to assess and implement required changes.
Non-conformances, CAPA & Complaints
- Manage non-conformances, corrective and preventive actions (CAPA), audit findings and root-cause investigations, ensuring actions are proportionate, effective and completed within agreed timescales.
- Analyse quality issues and performance data to identify trends, reduce recurrence and drive continual improvement.
- Support complain handling and post-market quality activities, ensuring significant issues are escalated and regulatory reporting requirements are considered with Regulatory Affairs.
- Maintain effective change-control, document-control and record-control processes.
Audits & Supplier Quality
- Plan and conduct the internal audit programme and host external certification, customer and regulatory audits or inspections.
- Coordinate timely responses to audit and inspection findings and monitor resulting actions through to effective closure.
- Manage supplier quality activities, including qualification, monitoring, audits and supplier non-conformances, in collaboration with relevant operational teams.
Product, Process & Risk Management
- Ensure applicable cGMP requirements and quality procedures are implemented and maintained throughout the business.
- Provide quality input into design and development, verification and validation, risk management, product or service changes and technical documentation.
- Support the application of medical-device risk-management principles, including ISO 14971 where applicable.
- Coordinate quality training and monitor completion and effectiveness of required QMS training.
Collaboration & Quality Support
- Work with the Regulatory Affairs Manager to define and implement the quality strategy and provide quality support for regulatory compliance activities.
- Support customers during vendor audits, respond to quality queries, demonstrate compliance and help manage complaints.
- Work with operational and development teams to ensure the QMS is understood, implemented and maintained and that new or changed products and services are appropriately verified and validated.
- Support information security management activities, including ISO/IEC 27001 requirements, where these interface with the QMS.
- Undertake other reasonable duties and general office activities appropriate to a small and growing team.
You will work with:
Regulatory Affairs Manager
Senior Leadership Team
Development and Product teams
Manufacturing, Operations and Logistics
Commercial and Data Services teams
Employees across the wider business
Suppliers and other external service providers
Certification bodies, auditors and regulatory authorities
Candidate Attributes
· Relevant degree, professional qualification or equivalent practical experience in medical-device quality management.
· Significant experience managing or leading quality assurance activities within a regulated medical-device environment.
· Strong working knowledge of ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820.
· Practical experience of QMS management, CAPA, non-conformance investigations, root-cause analysis, internal and external audits, document control and quality metrics.
· Ability to work autonomously, prioritise effectively and make sound, evidence-based judgements while escalating material risks appropriately.
Skills & Behaviours
· Methodical and analytical, with strong attention to detail and a practical approach to problem-solving and continual improvement.
· Clear and confident written and verbal communicator, able to explain quality requirements and work collaboratively across the business.
· Able to influence constructively, maintain professional judgement and meet agreed targets and timescales.
Desirable Experience & Knowledge
· Experience within the electronics, engineered-device or connected-health sectors.
· Knowledge of ISO 14971 medical-device risk management and experience supporting design, verification and validation activities.
· Experience implementing, administering or improving an eQMS.
· Experience of information security management systems, including ISO/IEC 27001:2022.
Benefits:
- Company events
- Company pension
- Free parking
- Life insurance
- On-site parking
- Private medical insurance
Ability to commute/relocate:
- Kimbolton PE28 0LF: reliably commute or plan to relocate before starting work (preferred)
Application question(s):
- Do you have excellent knowledge of ISO13485 and 21 CFR 820
Education:
Experience:
- medical device quality management: 3 years (required)
Work authorisation:
- United Kingdom (required)
Work Location: In person
