Senior Quality Engineer, Medical Devices | 6-Month Contract

SRG; Lancashire; Sur place; GBP 35 000 - 48 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality engineering

Regulated environment

Analytical thinking

Stakeholder management

Problem solving

Root cause analysis

Formation

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

Description du poste

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.