Management System Auditor - Fast Hire

Technical personnel requirement

Qualification

Completed a university or a technical college degree or equivalent qualification in one or more of the following fields-
(i) medical physics, 
(ii) biomedical engineering; biology or microbiology or biotechnology;
(iii) chemistry or biochemistry;
(iv) computer or software technology;
(v) electrical, mechanical or bioengineering;
(vi) human physiology;
(vii) medicine, dentistry, biomedical;
(viii) pharmacy; 
(ix) physics or biophysics; or
(x) other relevant fields

Work experience of technical personnel

Minimum of four years of full-time work experience in medical device related industry, especially:
1. research and development, manufacturing;
2. health care services and with patients;
3. testing the devices concerned for compliance with the relevant national or international standards;
4. conducting performance testing, evaluation studies or clinical trials of the devices; or
5. substantial relevant experience in e.g. the diagnostic, medical devices or pharmaceutical industries, the health care professions, medical laboratories or test institute.

FYI
*The number of years for total work experience may be reduced if the technical personnel has completed appropriate post-tertiary education. The reduction shall be as follows in the relevant technical area:
a) Masters – 1 year
b) PhD – 3 years

For extension to a new technical area involving class B medical device (only), the technical personnel shall have competence through relevant education and training in the new technical area, and either:
a) a minimum of one year work experience in the technology of the technical area; or
b) participated in ISO 13485 audits in four organisations under the supervision of a registered auditor in the technical area.

Addition : - 

1) has attended LA course for ISO 13485 and ISO 9001
2) priority will be given to candidate who has passed MDA examination and has obtained approval as MDA auditor
3) good reporting skill
4) experience in handling product verification and full conformity assessment