- Experience Range: 6-8 years
- Job Location: Hanoi
- Duty & Responsibilities:
– Identification of applicable regulatory standards and requirements for said Medical devices
– Classification of Medical devices based on USFDA, TPD, MDD, PAL and other National/Regional regulations
– Identification of ‘Substantially Equivalent’ devices with proper justification
– Interpretation of standards’ requirement statements and assist project team to derive design requirement statements
– Identification of applicable safety and compliance tests
– Coordinate with external test labs for safety/compliance test
– Preparation and compilation of Technical Files for regulatory submission
– Support project teams for DHF and DMR preparations
– Effort and timeline estimation for regulatory activities for project planning
– participate in review meetings to ensure regulatory compliance in project deliverables
– Creating awareness to design Engineers on Medical Device regulations, through facilitation, conducting training programs
– Support QAD for QMS process improvement activities and during internal/external audits
– Extensive knowledge on QMS standards like ISO 9001, IATF 16949 (ISO/TR), ISO 22000, ISO 13485 – Working experience as Management Representative (MR) in ISO certified company.
– Contributed for Quality Management System by authoring processes, implementation and/or training for effective implementation
– Extensive experience in Incoming, in-process and/or final inspection
– Working experience in healthcare institute (hospital/test lab) for installation, training and maintenance of Medical devices/IVD devices
– As Auditee faced auditing by independent agencies like Govt body, TUV, BSI, DNV, UL
– Good understanding of CAPA lifecycle and root-cause analysis and techniques involved
– Lead Auditor or Internal Auditor training in any of the QMS standard will be an added advantage
– Green/Black belt in Six sigma
– Good interpersonal skills
– Ability to work in a timeline driven environment
– Educational Qualification: Graduate in Science or Engineering (Bio-Medical, Electrical, Electronics, Mechanical)
– Total working experience: 8-10 Yrs. Relevant experience: 6+ Yrs
– Salary up to 1500$
– Insurance plan based on full salary + 13th salary + Performance Bonus.
– 100% full salary from the 1st day of working and during WFH. Medical Benefit (Bao Viet Insurance package) for Employee and Family.
– Working in a fast paced, flexible, and multinational working environment. Chance to travel onsite (in 49 countries).
– Internal Training (Technical & Functional). Scope of English Training.
– Working time: 8:30 am-6:00 pm from Mondays to Fridays.
– 18 paid leaves per year (including 12 annual leaves + 6 personal leaves)
- Preferred Language for Application: English