Technical lead 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
13d
Lead Designer
Steel Build Ltd —Bedford
- £50,156 - £58,675 a year
- Full-time
- Mentoring
- Free parking
- Referral programme
Quick apply
5d
Director of Systems & Transformation
Trade Mastermind Limited —Peterborough
- £120,000 - £150,000 a year
- Full-time
- In-person
- Free parking
Quick apply
3d
Quality and Environmental (Technical Services Coordinator)
East Anglian Galvanizing Limited —Huntingdon
- Up to £35,000 a year
- 8 hour shift
- Computer literacy
- Quality control
- In-person
- Free parking
- Store discount
Quick apply
14d
Senior Operations Coordinator
RSP UK —Bedford
- £32,000 - £34,000 a year
- Full-time
- Supervising experience
- Continuous improvement
- Team management
Quick apply
4d
Factory Technical Manager
Billington Foods —Wellingborough
- Up to £42,000 a year
- Full-time
- Presentation skills
- In-person
- Leadership
- Free parking
- Life insurance
Quick apply
Marketing Executive
Tensor —Saint Neots
- From £26,500 a year
- Full-time
- Social media management
- Organisational skills
- In-person
- Free parking
- Annual leave
Quick apply
6d
Head of Manufacturing UK
Aliaxis UK Limited (United Kingdom) —Huntingdon
- Full-time
- Management
- Engineering
- Continuous improvement
- Employee assistance programme
- Employee discount
7d
Deputy Chief Information Officer (Digital Services)
East of England Community Health and Care NHS Trust —Saint Ives
- £94,356 - £108,814 a year
- Full-time
- Travel
5d
Production Line Technical Lead
Brioche Pasquier —Milton Keynes
- £42,000 - £50,000 a year
- Full-time
- Computer literacy
- Maintenance
- Continuous improvement
- Employee discount
- Sick pay
Quick apply
Senior Analyst
Cambridgeshire County Council —Papworth Everard
- £46,956 - £50,157 a year
- Hybrid work
- Data analysis skills
- Analysis skills
- Organisational skills
- Annual leave
- Employee discount
Network and Telecoms Technical Lead
RS Group —Corby
- Remote
- Continuous improvement
- Communication skills
- Annual leave
- Employee assistance programme
Senior IT Infrastructure Manager
Cable Security Network UK Ltd. —Cambridge
- £75,000 - £100,000 a year
- Full-time
- Azure
- Computer Science
- Master's degree
- Free parking
- Health & wellbeing programme
Quick apply
Lead Gardener
ABMC Cambridge American Cemetery —Cambridge
- Up to £59,000 a year
- Maintenance
- English
- Supervising experience
- Life insurance
- Sick pay
Quick apply
11d
Senior Engineering Manager, Platforms and Infrastructure
Anglian Water Services Ltd —Huntingdon
- £75,000 a year
- Full-time
- Hybrid work
- DevOps
- Continuous improvement
- Team management
- Work from home
23h
Digital Transformation Manager
Jacqulin Digital Ventures Ltd —Cambridge
- £3,800 - £6,500 a month
- Full-time
- Analysis skills
- Project management
- Bachelor's degree
Quick apply
12d
Technical Support Team Lead
Kinetic Software —Milton Keynes
- Hybrid work
- Team management
- Training & development
- Leadership
- Employee assistance programme
- Employee discount
Head of Chemistry
Photocentric —Peterborough
- Full-time
- Project management
- Continuous improvement
- Organisational skills
Quick apply
Technical Project Manager
Levidian Nanosystems Ltd —Cambridge
- £60,000 - £75,000 a year
- Full-time
- PMP
- Engineering
- Travel
- Health & wellbeing programme
- Flexitime
Quick apply
4d
Hospitality Supervisor
Thomas Franks Ltd —Huntingdon
- £27,339 a year
- Overtime
- Computer literacy
- English
- Quality control
- Employee assistance programme
- Employee discount
Quick apply

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Quality Assurance Manager

Activinsights Ltd
Kimbolton

Quick apply

Job details

Full-time | Fixed term contract
13 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

technical lead jobs in kimbolton, cam

Quality Assurance Manager

Lead Designer

Director of Systems & Transformation

Quality and Environmental (Technical Services Coordinator)

Senior Operations Coordinator

Factory Technical Manager

Marketing Executive

Head of Manufacturing UK

Deputy Chief Information Officer (Digital Services)

Production Line Technical Lead

Senior Analyst

Network and Telecoms Technical Lead

Senior IT Infrastructure Manager

Lead Gardener

Senior Engineering Manager, Platforms and Infrastructure

Digital Transformation Manager

Technical Support Team Lead

Head of Chemistry

Technical Project Manager

Hospitality Supervisor

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