Quality Engineer

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, analyze, 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.

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