Quality Assurance Specialist

About the role

Device Technologies is seeking a proactive Quality Assurance Specialist to strengthen and evolve its Quality Management System within a highly regulated medical device environment. You will be a key member of the Regulatory Affairs & Quality Assurance (RAQA) team, driving compliance, leading audits, and supporting continuous improvement initiatives.

Key responsibilities

• Maintain and enhance the organisation’s Quality Management System (QMS) to meet ISO and regulatory requirements.
• Plan, conduct, and report internal and external audits, ensuring corrective actions are implemented.
• Manage Non‑Conformance Reports (NCRs) and drive Corrective and Preventive Actions (CAPAs) to resolution.
• Collaborate with cross‑functional teams to identify improvement opportunities and implement continuous improvement projects.
• Support ongoing ISO certification processes and ensure documentation is current and compliant.

Required profile

• Minimum 3 years’ experience in the medical device or a related regulated industry.
• Strong hands‑on experience with Quality Management Systems in a regulated environment.
• Demonstrated ability to lead audits, manage NCRs and CAPAs, and drive continuous improvement.
• Detail‑oriented, proactive, and able to work both independently and collaboratively.
• Excellent written and verbal communication skills.

Required skills

• Quality Management Systems (QMS)
• Auditing
• Non‑Conformance Reports (NCR)
• Corrective and Preventive Actions (CAPA)
• Continuous Improvement methodologies