Quality manager Work, Jobs in Bluntisham, Cam (with Salaries)

Quality Assurance Manager
Activinsights Ltd —Kimbolton
- Full-time
- Bachelor's degree
- No degree
- In-person
- Free parking
- Life insurance
Quick apply
1d
Project Manager, Security Systems Engineer - EMEA
Tesla —Cambridge
- PMP
- Project management
- Travel
Production Team Leader
ADM —Little Walden
- Weekend availability
- English
- Supervising experience
Senior Manager - Corporate Tax Advisory & Compliance
KPMG —Cambridge
- Full-time
- Accounting
- Tax experience
22h
Change & Continuous Improvement Project Manager
Cross Keys Homes —Peterborough
- £51,277 - £53,976 a year
- Full-time
- Microsoft Office
- Project management
- Presentation skills
Head Of Compliance And Quality Assurance
Medirest —Cambridge
- £65,000 a year
- Hotel
- Analysis skills
- Leadership
- Employee discount
12d
Project Manager - Cambridge
Princebuild —Cambridge
- Full-time
- Microsoft Office
- Bachelor's degree
- First Aid Certification
13d
Quality Performance Lead
Hain Celestial UK —Cambridge
- Night shift
- Communication skills
Quick apply
Line Leader Production
March Foods Ltd —March
- £13.25 - £16.58 an hour
- Full-time
- English
- In-person
- Free parking
- Bereavement leave
Quick apply
6d
Head of Quality Assurance and Regulatory Affairs
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Machine learning
- Annual leave
- Life insurance
Quick apply
6d
Quality Assurance Lead
LGC Assure —Fordham
- Full-time
- Project management
- SharePoint
- Communication skills
Quick apply
8d
Data Partnerships Project Manager
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Machine learning
- Negotiation
- Annual leave
- Life insurance
Quick apply
7d
Laboratory Team Leader - Contamination
SGS —Bar Hill
- From £28,000 a year
- Full-time
- Laboratory experience
- Bachelor's degree
- Contracts
- Annual leave
Quick apply
2d
Shopfitting / Fit Out Project Manager
Jaydee-Brook Ltd —Peterborough
- £65,000 a year
- Full-time
- Travel
- In-person
Quick apply
2d
Project Manager (AI models)
Qureight Ltd —Cambridge
- £56,000 - £61,000 a year
- Full-time
- Hybrid work
- Machine learning
- Communication skills
- Annual leave
- Life insurance
Quick apply
7d

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Quality Assurance Manager

Activinsights Ltd
Kimbolton

Quick apply

Job details

Full-time | Fixed term contract
1 day ago

Benefits

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

Qualifications

Quality management
Information security
Quality assurance
Bachelor's degree
Root cause analysis
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

quality manager jobs in bluntisham, cam

Quality Assurance Manager

Project Manager, Security Systems Engineer - EMEA

Production Team Leader

Senior Manager - Corporate Tax Advisory & Compliance

Change & Continuous Improvement Project Manager

Head Of Compliance And Quality Assurance

Project Manager - Cambridge

Quality Performance Lead

Line Leader Production

Head of Quality Assurance and Regulatory Affairs

Quality Assurance Lead

Data Partnerships Project Manager

Laboratory Team Leader - Contamination

Shopfitting / Fit Out Project Manager

Project Manager (AI models)

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