I. Position Summary
This position is responsible for design dossier review biocompatibility part during high risk medical devices product certification,
II. Job Responsibilities:
1. Performing technical review/audit according to standard requirements, regulatory requirements, internal requirements, code of conduct.2. Conduct seminar as assigned.3. Support sales and marketing activities in technical issues.4. Perform other duties assigned by Department Manager.
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Manager
Employment Type: Permanent Job, Full Time
1. Master degree in Microbiology/ Toxicology/Biology or equivalent.
2. Minimum 5 years working experience in the fields of medical devices testing as per ISO 10993 parts in ISO 17025 accredited laboratories OR Minimum 8 years working experience in the medical devices manufacturing involving in testing as per ISO 10993 various parts.
3. Good understanding and fulfillment to working related targets, standards, policies, procedures and instructions.
4. Respect and safeguard companys image, reputation and benefit.
5. Diligence, self-motivation, self-improvement and strong teamwork spirit.
6. Good communication, interpersonal and public relations skills.
7. Excellent command over English language.
8. Can work independently, efficiently and characterized with flexibility and resilience.
9. Good experience in handling of MS office applications & computer skills
10. Physical condition allows normal working, stable outputs and business trip as required.
Master degree in Microbiology/ Toxicology/Biology or equivalent.
PG – MS/M.Sc(Science) – Biology, Microbiology