Quality Engineer

SRG; Lancashire; On-site; GBP 35,000 - 48,000; Full time

Job summary

SRG is seeking an experienced Quality Engineer to support the quality management system and ensure compliance across development and manufacturing of medical technologies. You will work with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to meet regulatory and customer requirements.

The role focuses on investigations, CAPAs, risk management, and continuous improvement within a regulated environment, contributing to patient safety and product quality worldwide.

Qualifications

• Experience in Quality Engineering or QA in medical devices or regulated industry.
• Knowledge of ISO 13485 and medical device quality requirements.
• Experience managing CAPAs, non-conformances, and investigations.
• Strong communication and problem-solving skills.

Responsibilities

• Support and maintain the QMS in compliance with ISO 13485 and FDA QSR.
• Lead investigations into non-conformances, deviations, complaints and CAPAs.
• Conduct root cause analysis and implement corrective actions.
• Support audits and regulatory inspections.
• Review quality documentation and validation reports.
• Drive continuous improvement across manufacturing and operations.
• Support risk management per ISO 14971.
• Monitor quality metrics and supplier quality.
• Participate in design transfer, validation, and lifecycle quality activities.

Skills

Quality engineering

Regulated environment

Analytical thinking

Stakeholder management

Problem solving

Root cause analysis

Education

Bachelor's degree in Engineering, Science, Quality, or related discipline

Job description

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.