Job Description

1. Assist AVP-QA develop complete procedures and processes, implementing relevant quality and regulatory compliance system in line with the requirements of certification for applicable systems including but not limited to ISO 9001, Good Distribution Practices for Medical Devices (GDPMD), ISO 17025, ISO 13485, ISO 20000-1, ISO 27001 and others as applicable. 2. Maintain all established quality and regulatory systems according to the relevant certification requirements. 3. Ensure compliance in all process to Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738 inclusive registration of medical device. 4. Plan and conduct internal compliance audits , across all departments processes and report to the Management on the outcome of such audits. 5. Carry out risk management analysis and suggest solutions including but not limited to making any changes to processes to comply with applicable standards; 6. Assist AVP QA preparing audit report, 7. Coordinate with all department /state office to ensure time closure of any non-conformities. 8. Carry out other task as assign by superior.
OUR VISION QMS aims to be Partner-of-Choice for clinical engineering maintenance and management solutions in Malaysia and globally. OUR MISSION At QMS, we are committed to provide excellent, innovative services and solutions to our valuable customers. We strive to meet or exceed customer expectations, deliver superior and sustainable stakeholder value which truly transcends boundaries and transform lives. We specialised in the provisioning of turnkey solutions for biomedical clinical engineering services, maintenance and management. We leverage in our teams\xe2\x80\x99 collective technical knowledge and extensive understanding in healthcare technology sector. We adopt local and international quality standards which is implemented through an integrated centralised clinical engineering maintenance and management services at over three thousand (3,000) MOH Health clinics nationwide. MOH is Ministry of Health, Malaysia. Our workforce team comprises of over 250 experienced Biomedical Engineers, who have provided quality technical supports for more than 73,000 hours yearly to the users at MOH Health clinics. Our logistical mobility can easily cater to various remote MOH Health clinics nationwide, especially in geographical challenge states of Sabah and Sarawak, which certain areas are only accessible via off roads vehicles and boats. We pride ourselves in having Adaptability, Depth of Knowledge and Excellent technical services in the industry.
Diploma / Advanced Diploma / Higher Graduate Diploma / DVM / DKM Level 4 / DLKM Level 5