Quality Affairs Executive

at  Respiree Pte Ltd

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) IS0 13485 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

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

• Lead the technical documentations specific to the D&D processes in the Product Development team;
• Review and verify document records and ensure the documentation complies with Quality Management System (QMS), regulations and internal quality requirements;
• Checks format and conformance to document templates
• Ensure all documentation are reviewed, approved and effective dated as per Document Management System;
• Ensure the timeliness and order of the documentation of the D&D processes;
• Responsible for filing and maintenance of all controlled documents and records;
• Coordinate activities of QA documentation including assisting in assembly of traceability documentation;
• This position is the primary technical writer for documents pertaining to quality and regulatory requirement;
• Work with RAQA to ensure overall technical documentation of the product team are in order;
• Participate in both QMS and regulatory audits;

Provides additional support and assistance on tasks and projects as directed by Supervisor.
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