Medical Device Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team at DNV. In this role, you will be responsible for ensuring the highest standards of quality in the design, manufacture, testing, and use of medical devices.
About UsDNV is a leading global provider of risk management and quality assurance services. Our mission is to empower industries to create a safer world. As an equal opportunity employer, we welcome applicants from diverse backgrounds.
Responsibilities- Execute ISO13485 audits and other tasks arranged by the company, providing timely feedback to customers and the company on audit findings.
- Actively participate in relevant training and witnessing work to maintain auditor qualification.
- Take the initiative to learn and continuously improve auditing skills to provide valuable advice and recommendations to clients.
- Understand customer needs during audits and provide feedback to relevant departments.
- Rlevant bachelor or higher degree related to medical science and medical device area, such as biology, microbiology, biomechanical engineering, chemistry, biochemistry, medicine, clinic practice, computer and software technology, electrical, electronic, mechanical, or bioengineering.
- A minimum of 4 years' experience in the design, manufacture, testing, or use of medical devices in the industry, laboratory, or hospital.
- Auditing experience and registered QMS of CCAA auditor, with experience in other Notify Body being preferable.
- Good communication and teamwork skills, with fluent written and spoken English.
- Estimated salary: $90,000 - $120,000 per annum, depending on experience and qualifications.
- Flexible work arrangements for better work-life balance.
- Generous paid leaves, including sick leave, annual leave, and bereavement leave.
- Comprehensive medical benefits, including annual health check-ups.
- Pension and insurance policies, including pension insurance, medical insurance, unemployment insurance, work-related injury insurance, and supplementary pension.
- Training and development assistance, including training sponsorship, on-the-job training, and training programs.
- Additional benefits, including long service awards, mobile phone reimbursement, housing fund, and lunch policy.
- Profit share and Chinese New Year bonus.
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