Quality Engineer

SRG; London Borough of Ealing; On-site; GBP 40,000 - 60,000; Full time

Job summary

SRG in the United Kingdom seeks a motivated Quality Engineer to maintain and improve the QMS and ensure compliance with ISO 13485 and medical device regulations. You will work cross-functionally with internal teams, suppliers, and external stakeholders to drive continuous quality improvements.

The role focuses on document control, CAPA, change control, risk management, internal audits, and product release processes, ensuring robust quality data analysis and proactive regulatory compliance.

Qualifications

• Practical experience working within an ISO 13485 certified medical device QMS.
• Knowledge of applicable medical device regulations, standards, and guidance.
• Experience supporting supplier quality management activities.
• Experience participating in audits and regulatory/commercial requirements.

Responsibilities

• Maintain and support the Quality Management System (QMS) and regulatory compliance.
• Lead document control, CAPA, change control, and risk management activities.
• Conduct internal audits and support post-market surveillance.
• Review quality records and release documentation for compliance.
• Analyse quality data to identify trends and drive improvements.
• Investigate quality issues and implement effective corrective actions.
• Collaborate with suppliers and contract manufacturers to ensure quality.
• Prepare and present quality metrics and management information.

Skills

ISO 13485 QMS

Document Control

CAPA

Change Control

Risk Management

Internal Auditing

Product Release

Analytical Skills

Communication

Stakeholder Management

Job description

About the Role

We are looking for a motivated and detail-oriented Quality Engineer to join our team. This is an exciting opportunity for an experienced quality professional to play a key role in maintaining and improving our Quality Management System (QMS) while ensuring compliance with applicable Medical Device Regulations, International Standards, and customer requirements.

The successful candidate will work closely with internal teams, suppliers, and external stakeholders to support quality assurance activities, drive continuous improvement initiatives, and help ensure the highest standards of product quality and regulatory compliance.

Key Responsibilities

Maintain and support the effectiveness of the Quality Management System (QMS), including:

• Document Control
• CAPA (Corrective and Preventive Actions)
• Change Control
• Risk Management
• Internal Audits
• Vigilance
• Post-Market Surveillance (PMS)
• Supplier Management

Support product monitoring, assessment, and release activities.

Review and maintain quality records and documentation to ensure compliance with applicable regulations and standards.

Prepare, analyse, and present quality data to identify trends, support investigations, and drive continuous improvement initiatives.

Participate in root cause investigations, non-conformance management, CAPA activities, and implementation of corrective actions.

Collaborate with suppliers and subcontractors to ensure product and process quality requirements are met.

Review supplier quality documentation, including:

• Batch Records
• Certificates of Analysis (CoAs)
• Certificates of Conformity (CoCs)
• Sterilisation validation and release documentation

Support internal, supplier, customer, and regulatory audits.

Contribute to strategic quality and regulatory projects to improve processes and strengthen compliance across the business.

Stay informed of emerging regulatory requirements and industry best practices within the medical device sector.

About You

The ideal candidate will have a strong quality background within the medical device industry and a practical understanding of ISO 13485 Quality Management Systems.

Essential Skills and Experience

Practical experience working within an ISO 13485 certified medical device Quality Management System.

Good understanding of:

• Document Control
• CAPA
• Change Control
• Risk Management
• Internal Auditing
• Product Release Processes

Working knowledge of applicable medical device regulations, standards, and guidance.

Experience supporting supplier quality management activities.

Strong analytical and problem-solving skills with the ability to interpret quality data and identify trends.

Experience investigating quality issues and implementing effective corrective actions.

Excellent communication and stakeholder management skills.

Strong organisational skills with the ability to manage multiple priorities and deadlines.

Proactive, self-motivated, and committed to continuous improvement.

Desirable

Lead Auditor qualification or Internal Auditor experience.

Experience working with external manufacturers or contract manufacturing organisations.

Knowledge of UK MDR, EU MDR, and post-market surveillance requirements.

Experience participating in regulatory or notified body audits.