A) Quality Assurance
- Get in assisting and implementing and managing Quality System Tools administration, training, and auditing (as Customer Complaints/CAPA/Training/Control Documents/Standards).
Verify the compliance of quality procedures and work instructions with predefined and new mandatory standards.- Ensure that the Companys quality assurance and control system complies with the procedures and working instructions through audits, training, and preventive, and corrective actions.
Ensure process and product meet quality requirements set for each operation.
B) Regulatory Affairs
- Generation and maintenance of technical files for medical devices
Regulatory submissions in various countries.- Regulation requirements support all areas of company activities.
Submit medical device adverse and field corrective actions reports and recall notifications.
- Shall participate in cross-functional design review teams to review all product improvement Design Inputs and potential Defect Reports.
Shall take additional responsibilities as instructed by Superiors.
Based in Setia Alam Office.
- Working Days: Monday to Friday
Working hours: - 00 a.m. to 5.00 p.m.
- Lunch time: 1 hour break between 12:00 p.m. to 2:00 p.m.
Possess at least Bachelors Degree in Engineering, Business Admin or any related courses.- 1 2 years of experience & fresh graduates are welcome to apply!
Possess own vehicle and willing to travel interstate and oversea.
- Have working experience in Medical Devices such as initiating, monitoring, and verifying the effective implementation of the Quality Management System in all areas of company activities.
Job Type: Full-time
Pay: From RM3,000.00 per month
Benefits:
Health insuranceSchedule:Supplemental Pay:
Ability to commute/relocate:- Setia Alam: Reliably commute or planning to relocate before starting work (Preferred)
Experience:- QA and RA: 1 year (Preferred)
Language:Willingness to travel:
100% (Preferred)
