Quality Affairs Executive - Singapore - RESPIREE PTE. LTD.

RESPIREE PTE. LTD.

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

beBee Recruiter

Description

**Roles & Responsibilities
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.

**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.