Jobs

    Quality Affairs Executive - Singapore - RESPIREE PTE. LTD.

    RESPIREE PTE. LTD.
    RESPIREE PTE. LTD. Singapore

    1 week ago

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    Description
    Roles & Responsibilities

    Roles & Responsibilities

    The QA Executive is responsible for Design and Development (D&D) processes and documentation that includes at least the following:

    1. Lead the technical documentations specific to the D&D processes in the Product Development team;
    2. Review and verify document records and ensure the documentation complies with Quality Management System (QMS), regulations and internal quality requirements;
    3. Checks format and conformance to document templates
    4. Ensure all documentation are reviewed, approved and effective dated as per Document Management System;
    5. Ensure the timeliness and order of the documentation of the D&D processes;
    6. Responsible for filing and maintenance of all controlled documents and records;
    7. Coordinate activities of QA documentation including assisting in assembly of traceability documentation;
    8. This position is the primary technical writer for documents pertaining to quality and regulatory requirement;
    9. Work with RAQA to ensure overall technical documentation of the product team are in order;
    10. Participate in both QMS and regulatory audits;
    11. Provides additional support and assistance on tasks and projects as directed by Supervisor.

    Competency & Awareness

    The requisite expertise shall be demonstrated with the following qualifications:

    (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in engineering or another relevant scientific discipline;

    (b) At least two years of professional experience in quality assurance practices in product management, project management and/or in quality and regulatory compliance relating to medical devices;

    (c) IS certified or knowledge in IEC 62304 standard;

    (d) Strong technical writing and proofreading.

    Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

    Tell employers what skills you have

    Document Management
    Technical Documentation
    Quality Control
    Regulatory Compliance
    Quality Management
    Technical Writing
    Quality Assurance
    ISO
    Traceability
    Product Management
    Compliance
    Project Management
    Medical Devices
    Audits
    Evidence
    Product Development
    Assembly
    Proofreading
    Manufacturing
    Audit


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