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Quality Affairs Executive - Singapore - RESPIREE PTE. LTD.
Description
Roles & ResponsibilitiesRoles & Responsibilities
The QA Executive is responsible for Design and Development (D&D) processes and documentation that includes at least the following:
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 haveDocument 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