Affairs manager Work, Jobs in Kimbolton, Cam (with Salaries)

Quality Assurance Manager
Activinsights Ltd —Kimbolton
- Full-time
- Bachelor's degree
- Continuous improvement
- No degree
- Free parking
- Life insurance
Quick apply
12d
Trading Standards Officer
Peterborough City Council —Peterborough
- £39,152 - £42,839 a year
- Remote
- Annual leave
- Employee discount
13d
(Senior) Global Medical Director, Established Brands
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Budgeting
- Leadership
Service Manager, Governance
Cross Keys Homes —Peterborough
- £69,061 - £72,696 a year
- Full-time
- Management
- Writing skills
- Project management
Events Manager - FTC
Compare the Market —Peterborough
- Hybrid work
- Organisational skills
- Budgeting
- Communication skills
Quick apply
Global Medical Advisor - Rescue Treatments
Mundipharma —Cambridge
- Full-time
- Doctoral degree
- Mentoring
- Budgeting
Regulatory Affairs Systems and Data Manager
Mundipharma —Cambridge
- Full-time
- Hybrid work
- Management
- Training & development
- Communication skills
Marketing Communications Manager
Cycle Pharmaceuticals —Cambridge
- Full-time
- Hybrid work
- Microsoft Word
- No degree
- Leadership
- Gym membership
- Flexible schedule
Regulatory Affairs Specialist
Cambridge Consultants —Cambridge
- Continuous improvement
- Leadership
Health, Safety & Environmental Coordinator
Solina Group —Biggleswade
Assistant Contract Manager
East West Rail —Milton Keynes
- Hybrid work
- Writing skills
- Contracts
- Annual leave
- Employee assistance programme
Quick apply
5d
Data Partnerships Project Manager
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Annual leave
- Life insurance
Quick apply
Land Engagement Manager
East West Rail —Milton Keynes
- Hybrid work
- CRM software
- Writing skills
- No degree
- Annual leave
- Employee assistance programme
Quick apply
4d
Business Development Proposals Manager
DLRC —Letchworth
- Salesforce
- Continuous improvement
- Organisational skills
4d
Clinical Site Manager
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Continuous improvement
- Organisational skills
- Time management
- Annual leave
- Life insurance
Quick apply
Project Manager (AI models)
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Life insurance
Quick apply
Land and Property Acquisition Manager
East West Rail —Milton Keynes
- Hybrid work
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Head of Programme Management
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Machine learning
- AI
- Communication skills
- Annual leave
- Life insurance
Quick apply
Land and Property Programme Manager
East West Rail —Milton Keynes
- Hybrid work
- Team management
- Contracts
- Annual leave
- Employee assistance programme
Quick apply
Tax Executive, Personal Tax Compliance Unit
Grant Thornton UK LLP —Milton Keynes
- Full-time
- Communication skills
- Tax experience
- Employee discount

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affairs manager jobs near kimbolton, cam

Quality Assurance Manager

Activinsights Ltd
Kimbolton

Quick apply

Job details

Full-time | Fixed term contract
12 days ago

Benefits

Free parking
Company pension
Company events
Private medical insurance
Life insurance
On-site parking

Qualifications

Document control
Non-conformance investigation
Quality management change control procedures
Internal quality management system auditing
Compliance audits
Complaint handling
Quality assurance
Bachelor's degree
Continuous improvement
Continuous improvement cycles oversight
Risk management
ISO 27001
Supplier quality management
Supply chain quality assurance
Root cause analysis
Quality management system (QMS) implementation
Internal quality assurance
ISO 13485
Corporate regulatory compliance oversight
FDA regulations

Full job description

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:

Bachelor's (preferred)

Experience:

medical device quality management: 3 years (required)

Work authorisation:

United Kingdom (required)

Work Location: In person

Quick apply

Refine Your Search

affairs manager jobs in kimbolton, cam

Quality Assurance Manager

Trading Standards Officer

(Senior) Global Medical Director, Established Brands

Service Manager, Governance

Events Manager - FTC

Global Medical Advisor - Rescue Treatments

Regulatory Affairs Systems and Data Manager

Marketing Communications Manager

Regulatory Affairs Specialist

Health, Safety & Environmental Coordinator

Assistant Contract Manager

Data Partnerships Project Manager

Land Engagement Manager

Business Development Proposals Manager

Clinical Site Manager

Project Manager (AI models)

Land and Property Acquisition Manager

Head of Programme Management

Land and Property Programme Manager

Tax Executive, Personal Tax Compliance Unit

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