Medical Device Quality Assurance Expert
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We are seeking an experienced medical device quality assurance professional to partner with us in designing and developing novel devices for treating intracranial atherosclerotic disease.
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The role requires expertise in quality and regulatory control of medical devices, ensuring product quality during early development phases through to commercialization. The position involves developing and supporting quality management system activities, batch release, internal audits, and supplier management.
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* Compliance with policies and procedures and applicable national and international regulations.
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* Leading compliance and improvement activities associated with the quality system (CAPA, audit programs, personnel training).
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* Applying systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
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* Planning, executing, reporting, and following up on quality system audits.
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* Providing expertise in quality assurance, controls, and systems to support and develop the quality management system.
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* Developing and implementing control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
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* Working closely with suppliers to ensure robust quality agreements are in place.
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* Providing ongoing support to internal teams in product development.
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* Gathering and analyzing data to support statistical rational sample testing requirements.
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* Preparing and maintaining detailed records of inspections, testing, and non-conformance reports.
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* Collecting, analyzing, and reporting key data related to product testing and supplier performance.
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* Using data-driven insights to drive continuous improvement initiatives.
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Requirements
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* A degree in quality engineering, life science, or a related field.
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* 3-5 years' experience in a quality assurance role in the medical device sector.
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* Quality certification and lead auditor certification an advantage.
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* Knowledge of FDA's 21 CFR Part 820 and ISO 13485:2016.
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* In-depth knowledge of quality engineering principles, methodologies, and tools.
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* Experience in QA activities associated with design and development of medical devices.
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* Results-driven with excellent interpersonal skills and ability to work effectively as part of a team.
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