APAC Regional Auditor (No. JLAL160519)
APAC VP Quality and Compliance
- Degree in Science, Medical Science, Biomedical Engineering or equivalent
- Qualified Lead auditor
SKILLS KNOWLEDGE EXPERIENCE
- A minimum of 4 years’ experience in the medical field related to quality management; internal/external auditing and relevant work experience.
- Be a qualified quality management system lead auditor for the medical device field.
- Extensive technical knowledge associated with the Medical Device field (Supplier management, raw materials, assembly, distribution, etc.)
- Extensive knowledge of worldwide medical device quality regulations
- Understanding of quality and quality management systems, especially familiarity with ISO 13485 and 21CFR820
- Understanding of statistics
- Strong attention to detail and commitment to compliance
- High degree of independence in approach
- Ability to multitask, prioritise and change focus when required
- Excellent written and verbal communication skills in English, with ability to summarize technical content for specific audiences
- Integrity and diplomacy
- Sensitivity to different cultural norms across APAC countries
- Practical laboratory skills (ELISA and lateral flow)
- Understanding of immunoassay principles
- Other Asian language proficiency
LEVEL OF SUPERVISION
- Does not require review of routine work
- Seeks guidance on unusual features
- Plan external audit schedules for APAC
- Lead audits of Company facilities across APAC.
- Lead audits of Company suppliers across APAC.
- Audit according to ISO Standards (to ISO 9001, ISO 13485, etc.)
- Inspection according to the US FDA Quality System Regulation
- Audit for the CE Marking of Medical Devices (all directives / all devices / all assessment modules)
- Audit for access to other major markets including Australia, Canada, Brazil
- Train internal auditors
- Align global audit schedules with peer regional auditors in Americas and Europe.
- Provide audit coaching to Company staff
- Keep informed of regulations for defined jurisdictions
- Prepare and issue reports
- Maintain audit related records in global Oracle Agile system.
- Supervise closure of corrective actions.
- Travel frequently within APAC and sometime globally.
METRICS OF SUCCESSFUL ROLE PERFORMANCE
- Deliver on-time and in-full performance of agreed audit schedule
- No interruption to business continuity from approved suppliers for reasons within the control of the position.
- Satisfaction described by supervisor
- Advanced level of English