Posted: 11h ago
The role
This role offers an excellent opportunity to work within a highly regulated ISO 13485 environment, supporting quality assurance, regulatory compliance, distribution quality oversight, and continuous improvement initiatives across distribution and operational networks. The successful candidate will play a key role in maintaining quality system compliance, supporting investigations, and driving process improvements.
Key Responsibilities
Support quality assurance programmes, procedures, and controls for medical devices and finished goods.
Review, plan, coordinate, and implement change controls while assessing quality and regulatory impact.
Collaborate with Manufacturing Engineering and Operations teams on risk assessments, process improvements, and quality initiatives.
Lead and support investigations relating to non-conformances, CAPAs, and quality system issues.
Conduct root cause analysis and implement effective corrective and preventive actions.
Monitor quality performance trends and utilise statistical tools to identify improvement opportunities.
Support validation activities, including strategy development, sampling plans, and execution for new and existing product lines.
Ensure compliance with ISO 13485, Quality Management Systems (QMS), and applicable regulatory requirements.
Identify potential quality and compliance risks and support mitigation activities.
Drive continuous improvement projects to enhance operational efficiency and maintain regulatory compliance.
Work closely with Supply Chain, Operations, and Engineering teams to ensure effective quality oversight.
Skills & Experience
Bachelor's Degree in Engineering, Science, or a related discipline.
3-5 years' experience within a regulated Medical Device environment.
Strong working knowledge of ISO 13485 and Quality Management Systems (QMS).
Experience managing change controls, CAPA investigations, and non-conformance processes.
Knowledge of risk management methodologies, including FMEA (Failure Mode and Effects Analysis).
Experience with root cause analysis and structured problem-solving techniques.
Strong communication skills with the ability to present technical information to both technical and non-technical stakeholders.
Proficient in Microsoft Office applications, including Excel, Word, and PowerPoint.
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