Quality Assurance Engineer - Medical Devices Overview We are seeking a Quality Assurance Engineer to support key quality and engineering activities within a regulated medical device environment. This role will contribute to product quality, process improvement, and compliance efforts while collaborating closely with cross‑functional engineering, operations, and R&D teams.
Responsibilities
Conduct structured root cause analysis using established engineering and quality tools (fishbone diagrams, failure analysis, decision trees, FMEA, etc.).
Evaluate product performance data, identify trends, and develop engineering‑driven recommendations to enhance product reliability and manufacturing processes.
Ensure quality documentation-including technical reports, investigations, and change records-is complete, accurate, and compliant with FDA, ISO 13485, and EU MDR standards.
Support regulatory and compliance activities, including audit preparation, data gathering, and representation as a Quality SME during internal and external audits.
Contribute to CAPA and NCR investigations by providing engineering insight and supporting the implementation of corrective and preventive actions.
Support product quality activities across the full lifecycle, including risk management, design review support, and process verification activities.
Collaborate with Engineering, Quality, Operations, and R&D teams to investigate product‑related issues and implement robust technical solutions.
Qualifications
Bachelor's degree in Engineering preferred
3-5 years of experience within the medical device industry
Strong engineering mindset with the ability to analyse technical data and troubleshoot product or process issues.
Excellent documentation, reporting, and analytical skills; proficiency in Microsoft Office (Excel, Word, PowerPoint).
Ability to work independently, manage multiple priorities, and maintain strong attention to detail.
Effective communicator with experience presenting technical findings to senior leadership and cross‑functional stakeholders.
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