Quality assurance manager Work, Jobs in Waltham Cross, Ess (with Salaries)

Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
11d
Quality Assurance Manager
Icely Done Drinks —Hoddesdon
- Up to £42,000 a year
- Full-time
- Bar
- Analysis skills
- Bachelor's degree
- Flexitime
- Sick pay
Quick apply
Quality Assurance Manager
Premier Knit Manufacturing —London
- £4,700 - £6,300 a month
- Full-time
- Analysis skills
- Continuous improvement
- In-person
- Store discount
- Employee discount
Quick apply
4d
Care Home Quality Improvement Manager
Excelcare Holdings —Bromley
- Up to £66,462 a year
- Full-time
- Hospital
- Care experience
- Travel
- Free parking
- Employee discount
Quick apply
Deputy Quality Assurance Manager
Imperial College Healthcare NHS Trust —London
- £58,133 - £65,261 a year
- Full-time
2d
Quality Assurance Manager
Toyota Connected Europe —London
- Hybrid work
- Continuous improvement
- Software development
- Leadership
Quality Assurance Manager
Regent College London —London
- £50,000 a year
- Full-time
- Project management
- No degree
- Organisational skills
Quick apply
TEST MANAGER - LEAD CONSULTANT
Scale Factory —London
- Hybrid work
- Driving
- Mentoring
- Agile
- Annual leave
Quality Assurance Manager
ION —London
- Full-time
- Software development
- Agile
- Financial services
3d
Quality Manager - Tutorials & Pastoral Care
LSEC —London
- £52,549 - £59,408 a year
- Full-time
- University
- Teaching
- Annual leave
- Employee assistance programme
Quality Product Manager
O-I —Harlow
- £55,000 - £63,000 a year
- Full-time
- Management
- Continuous improvement
- Communication skills
Quick apply
3d
Quality Assurance Manager
Lab49 —London
- Full-time
- Software development
- Agile
- Financial services
3d
Quality Compliance Manager
Inflite Engineering Services Ltd —Stansted
- Full-time
- Administrative experience
- Organisational skills
- Communication skills
Quick apply
Director of Quality
CECOS College London —London
- £80,000 - £100,000 a year
- Full-time
- Master's degree
- Analysis skills
- Project management
Quick apply
QA Lead
Product Madness —London
- Full-time
- Management
- Travel
- APIs
11d
Quality Assurance Manager
Taiko —Acton
- £45,000 a year
- Full-time
- Communication skills
- Employee discount
Quick apply
Manager, Quality Assurance
London Stock Exchange Group —London
- Full-time
- Management
- Computer Science
- DevOps
Quality Lead - £46,160-£51,666 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency —South Mimms
- £46,160 - £51,666 a year
- Full-time
- Presentation skills
- Bachelor's degree
- Travel
- Annual leave
- Sick pay
5d
Senior Quality Manager
Network Rail —Blackfriars Station
- £46,701 - £55,411 a year
- Full-time
- Analysis skills
- Continuous improvement
- Construction experience
- Annual leave
Supplier Quality Assurance Manager
Humanoid —London
- Full-time
- ERP systems
- Master's degree
- Travel
- Annual leave
Quick apply
4d

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quality assurance manager jobs near waltham cross, ess

Quality and Regulatory Manager

Advanced Healthcare Technology Ltd
Waltham Cross

Quick apply

Job details

Full-time
£50,000 - £60,000 a year
11 days ago

Benefits

Free parking
Casual dress
Company pension
On-site parking

Qualifications

Quality assurance
HACCP
Organisational skills
Root cause analysis
Internal audits

Full job description

Role Purpose

The Quality and Regulatory Manager is responsible for leading the company’s quality management and regulatory compliance activities to ensure that products are developed, manufactured, released and marketed in compliance with applicable requirements. This is a hands-on role with broad responsibility across the quality management system, technical documentation, post-market activities, supplier quality, internal auditing, and regulatory support for global market access. The jobholder will work closely with senior leadership and cross-functional teams to maintain compliance with applicable international medical device regulations and standards, including ISO 13485, MDSAP and relevant market-specific requirements.

Key Responsibilities

· Maintain and continuously improve the company’s Quality Management System in line with ISO 13485, MDSAP and applicable regulatory requirements.

· Manage the relationship between the company and key regulatory bodies including the company’s Notified Body / Auditors

· Ensure products are correctly classified for regulatory clearance in proposed markets.

· Support and maintain technical documentation, declarations of conformity, labelling compliance, and product records in line with product classification.

· Act as the internal lead for quality assurance and regulatory compliance.

· Plan and conduct internal audits and support external audits by certification bodies, regulatory authorities, customers, and other third parties.

· Manage non-conformances, deviations, CAPA, complaints, and change control processes.

· Support clinical evaluation and human factors processes to ensure that these are met throughout the product life cycle.

· Support post-market surveillance, vigilance reporting, field safety corrective actions, and trend analysis where required.

· Ensure document control processes are effective and that quality records are complete, accurate, and audit-ready.

· Work with Senior Management to ensure culture of compliance is embedded in business processes.

· Support supplier qualification, monitoring, and re-evaluation activities, including supplier audits where appropriate.

· Provide regulatory input for product changes, new product introduction, and international market expansion.

· Monitor changes in applicable regulations, standards, and guidance and assess their impact on the business.

· Coordinate management review inputs, quality metrics, and compliance reporting for leadership.

· Deliver training and guidance to staff on quality and regulatory requirements and promote a strong quality and compliance culture.

· Support product registration and market access activities in territories where the company sells its products, using external specialists where required.

Management Responsibilities

· Direct Reports – Currently none

· Consultants and contractors – as appropriate

Qualifications and Experience

· Degree or equivalent experience in a relevant scientific, engineering, quality, or regulatory discipline.

· Lead Auditor qualified or extensive experience with internal auditing, CAPA, complaints handling, supplier quality, and change control.

· Proven experience in quality assurance and regulatory affairs within the medical device sector.

· Strong working knowledge of ISO 13485 and medical device regulatory requirements relevant to Class I and II devices especially in the USA.

· Experience maintaining technical documentation and quality system records in a regulated environment.

· Experience supporting international regulatory compliance and market access activities is essential.

· Supervise quality and document control activities.

Key Skills and Attributes

· Ability to work independently and pragmatically in an environment with limited resources.

· Strong organisational skills, attention to detail, and the ability to prioritise across multiple responsibilities.

· Confident communicator able to work effectively across departments and with external stakeholders.

· Ability to interpret regulations and translate them into workable internal processes.

· Strong problem-solving and root cause analysis skills.

· Ability to influence without unnecessary bureaucracy.

· Comfortable balancing compliance requirements with business needs and operational realities.

· High integrity, accountability, and commitment to patient safety and product quality.

Reporting and Working Relationships

This role reports to the Managing Director.

Key relationships with manufacturing, engineering, supply chain, customer service, and commercial teams.

Pay: £50,000.00-£60,000.00 per year

Benefits:

Casual dress
Company pension
Free parking
On-site parking

Work Location: In person

Quick apply

Refine Your Search

quality assurance manager jobs in waltham cross, ess

Quality and Regulatory Manager

Quality Assurance Manager

Quality Assurance Manager

Care Home Quality Improvement Manager

Deputy Quality Assurance Manager

Quality Assurance Manager

Quality Assurance Manager

TEST MANAGER - LEAD CONSULTANT

Quality Assurance Manager

Quality Manager - Tutorials & Pastoral Care

Quality Product Manager

Quality Assurance Manager

Quality Compliance Manager

Director of Quality

QA Lead

Quality Assurance Manager

Manager, Quality Assurance

Quality Lead - £46,160-£51,666 p.a. + benefits

Senior Quality Manager

Supplier Quality Assurance Manager

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