Quality Management System Auditor
2 months ago
Position Overview: This opportunity is centered around the certification of medical devices. The key responsibilities associated with this position include:
- Achievement of KPI Targets: Take ownership of personal performance metrics.
- Implementation of Auditing Standards: Conduct ISO13485 and MDR auditing and assessment for clients, adhering to CE Directives and international standards.
- Integrity in Execution: Ensure that all work is carried out with utmost independence and ethical standards.
- Operational Improvement: Actively seek enhancements in audit processes and information management to boost team efficiency.
- Project Management: Organize and execute assessments, gap analyses, training sessions, and workshops for clients.
- Registration Maintenance: Keep auditor registration with relevant authorities to serve as a Lead Auditor.
- Additional Responsibilities: Undertake other tasks as assigned by management.
- Flexible Work Arrangements: Enjoy options that promote a healthy work-life balance.
- Generous Leave Policies: Benefit from comprehensive sick leave and annual leave policies.
- Health Benefits: Participate in annual health check-ups and medical benefits.
- Pension and Insurance: Access various insurance policies including medical, unemployment, and work-related injury insurance.
- Training Opportunities: Engage in training sponsorship and on-the-job training programs.
- Additional Perks: Enjoy long service awards, mobile phone reimbursement, and a lunch policy.
- Profit Sharing: Benefit from profit-sharing schemes and bonuses during festive seasons.
Note: Benefits may vary based on position and tenure.
Diversity Commitment: DNV is dedicated to fostering an inclusive workplace and considers all qualified applicants without discrimination based on gender, religion, race, national origin, disability, or any other characteristic.
Qualifications:
- Relevant bachelor’s degree or higher in medical science or related fields such as biology, engineering, or computer technology.
- 2-4 years of experience in the medical device industry, with a preference for clinical experience.
- Auditing experience and registration as a QMS auditor is advantageous.
- Strong customer focus and excellent communication skills.
- Fluency in English, both written and spoken.
- Willingness to manage a high workload and travel frequently.
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