Quality Affairs Executive

Roles & Responsibilities

The QA Executive should have expertise in software development lifecycle processes and IEC 62304 standard, and 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. Implement and oversee quality assurance policies and procedures to ensure compliance with IEC 62304 and other relevant standards.
3. Collaborate with software developers and Product team to integrate quality assurance measures into all stages of the software development lifecycle.
4. Guide the software testing team in developing effective test plans and strategies based on regulatory standards.
5. Review and verify document records and ensure the documentation complies with Quality Management System (QMS), regulations and internal quality requirements;
6. Monitor and report on software defects and track their resolution.
7. Checks format and conformance to document templates
8. Ensure all documentation are reviewed, approved and effective dated as per Document Management System;
9. Ensure the timeliness and order of the documentation of the D&D processes;
10. Responsible for filing and maintenance of all controlled documents and records;
11. Coordinate activities of QA documentation including assisting in assembly of traceability documentation;
12. This position is the primary technical writer for documents pertaining to quality and regulatory requirement;
13. Work with RAQA to ensure overall technical documentation of the product team are in order;
14. Conduct thorough internal reviews and audits of software development processes to identify potential quality issues and areas for improvement.
15. Participate in both QMS and regulatory audits;
16. Prepare and maintain detailed reports on quality assurance activities and findings.
17. Provides additional support and assistance on tasks and projects as directed by Supervisor.
18. Train and support team members on quality assurance best practices and compliance with IEC 62304.
19. Stay informed about the latest developments and changes in regulatory standards affecting software development in the medical device industry.

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 Quality Management, Software Engineering, or a related field;

(b)  minimum of 3 years of professional experience in quality assurance practices in product management, project management and/or in quality and regulatory compliance within the software development for medical devices;

(c) Experience with IS0 13485, FDA and other regulatory requirements applicable to medical device software is highly beneficial;

(d) Extensive knowledge of software development lifecycle and expertise in IEC 62304 standard;

(d) Strong analytical skills with a detail- oriented mindset;

(e) Strong technical writing and proofreading;

(f) Excellent organization and communication skills;

(g) Ability to lead and influence cross- functional teams.

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.