This position is responsible for conducting Medical Health Services audit.
1. The Medical Device Auditor, reporting to the MHS Manager, assesses non-active medical devices as well as their manufacturers by utilizing the knowledge of the European Medical Devices Directives, other applicable regulatory requirements, and recognized standards such as ISO 13485 and other International standards.
2. The Medical Device Auditor performs regulatory audits of clients per European Medical Device Directives, Canadian Medical Device Regulations, Japanese Pharmaceutical Affairs Law and International quality system standards specifically ISO 13485, as well as internal Notified Body. The auditor will conduct review to Quality System related tasks, such as management, design and development, corrective actions; as well as prepare reports and audit documentation for submission to the certification committee of the Notified Body
3. The Medical Device Auditor performs evaluations of product regulatory submissions including: Design Dossiers (Class III) and Technical Files (Class II), according to European Medical Device Directives.
4. Conduct seminar as assigned
5. Support sales and marketing activities in technical issues
6. Perform other duties assigned by Department Manager.
II. Responsibility and Authority
1. Registered auditor; Successfully completed 5 days lead auditor course for ISO 9001:2015
2. Good understanding and fulfillment to working related targets, standards, policies, procedures and instructions;
3. Respect and safeguard companys image, reputation and benefit;
4. Diligence, self-motivation, self-improvement and strong teamwork spirit;
5. Good communication, interpersonal and public relations skills;
6. Can work independently and efficiently; can work under pressure;
7. Good computer skill;
8. Good command of English;
9. Physical condition allows normal working, stable outputs and business trip as required.
2 Education and Experience
1. The Auditors should have academic degree (post-secondary education) in a technical or scientific
discipline from the technical institute or university is required. The Appropriate technical or scientific areas
cover the following.
Mechanical Engineering, bioengineering, chemical, ceramic or textile engineering.
Biology or Microbiology, Chemistry or Biochemistry, Human physiology, Medicine, Pharmacy, Polymer science
2. Minimum of four years of full-time work experience in Medical device related industry, including at least two
years of work experience in one or more of the following:
Closely related industries and the work place such as research and development, manufacturing;
The application of the device technology and its use in health care services and with patients;
Testing the devices concerned for compliance with the relevant national or international standards;
Conducting performance testing, evaluation studies or clinical trials of the devices
Salary: Not Disclosed by Recruiter
Role Category:Quality Assurance & Quality Control-Compliance & Regulatory
Role:Quality Assurance & Quality Control-Manager
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
TUV SUD SOUTH ASIA PRIVATE LIMITED
Contact Company:TUV SUD SOUTH ASIA PRIVATE LIMITED