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    • Quality Assurance Specialist - Oxford - Skills Alliance

    Skills Alliance
    Skills Alliance Oxford

    3 weeks ago

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    Description

    Position Summary

    A global medical device organization is seeking a meticulous and organized Quality Specialist, Internal Auditor – QMS to improve lives through advanced transplant technology.

    The Internal Auditor – QMS conducts internal audits across global sites to ensure compliance with company policies, quality standards, and applicable regulations.

    This role ensures company operations align with the Quality Management System (QMS).

    Responsibilities:

    • Conduct internal audits for FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
    • Evaluate organizational processes against defined quality standards.
    • Identify areas for improvement and propose corrective actions within the QMS.
    • Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
    • Prepare and present detailed audit reports to management.
    • Support development and implementation of corrective action plans based on audit findings.
    • Provide training and guidance to staff regarding quality standards and QMS principles.
    • Monitor and verify the effectiveness of implemented corrective actions.
    • Stay informed on the latest developments in relevant quality standards and regulations.
    • Comply with the company's Code of Conduct and all other corporate policies.

    Requirements:

    • University or college degree in a scientific or quality/regulatory discipline.
    • Minimum of 3 years of experience in medical device quality auditing, or a comparable combination of education and experience.
    • In-depth knowledge of medical device regulations including FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and CMDR.
    • Strong analytical skills and a focus on process improvement.
    • Ability to present findings clearly and respond professionally to stakeholders including management, customers, and suppliers.
    • High emotional intelligence and professional demeanor to ensure positive engagement with auditees during audits.
    • Proficiency in Microsoft Office tools (Excel, PowerPoint, Visio, Word, Access).
    • Strong organizational and time-management skills.
    • Experience in quality audits preferred; lead auditor certification in ISO 13485, MDR, or MDSAP is an asset.
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Quality assurance specialist