Quality Engineer

We are seeking an experienced and motivated Quality Engineer to join a growing medical device business on an initial 6 month contract.

This is an exciting opportunity to play a key role in maintaining and improving quality systems that support the development and manufacture of innovative medical technologies that positively impact patient outcomes worldwide.

Working closely with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supply Chain, you will help ensure products consistently meet regulatory, customer, and business requirements.

Key Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and applicable regulations.
• Lead investigations into non-conformances, deviations, complaints, and CAPAs.
• Conduct root cause analysis and implement effective corrective and preventive actions.
• Support internal, supplier, and external audits, including regulatory inspections.
• Review and approve quality documentation, including procedures, work instructions, and validation reports.
• Drive continuous improvement initiatives across manufacturing and operational processes.
• Support risk management activities in line with ISO 14971.
• Monitor quality metrics and identify opportunities for improvement.
• Work closely with suppliers to ensure material and component quality standards are maintained.
• Participate in design transfer, validation, and product lifecycle quality activities.

About You

You will be a proactive quality professional who thrives in a regulated environment and is passionate about delivering high-quality medical devices.

Essential Requirements:

• Degree in Engineering, Science, Quality, or a related discipline.
• Experience in a Quality Engineering or Quality Assurance role within the medical device, pharmaceutical, or highly regulated industry.
• Understanding of ISO 13485 and medical device quality requirements.
• Experience managing CAPAs, non-conformances, and root cause investigations.
• Knowledge of risk management and validation activities.
• Excellent communication and stakeholder management skills.
• Strong analytical and problem-solving abilities.

Guidant, Carbon60, Lorien & SRG - The Vertage Group Portfolio are acting as an Employment Business in relation to this vacancy.

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