ISO 13485 and GDPMD Auditors

Responsibilities:

• Conduct audits in accordance with the relevant regulations, quality standards, policies and other criteria for which assessment is required on the part of the auditor.
• Ensure effective and timely completion of such audits including the submission of audit reports.
• Develop and review audit methodologies for accreditation compliance.
• Develop and conduct related training courses.
• Conduct audit independently, professionally with impartiality.
• Submit audit report and audit packs accurately and timely as per KPI determined by the organization.
• Undergo training, authorization or otherwise any qualification process including evaluation deemed necessary by manager to be rendered suitable and/or competent for a specific task such as auditing and assessment of product and/or product documentation.
• To implement and comply to medical device laws and regulations of Malaysia.
• To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
• To plan, conduct and follow up on audits as assigned.
• Follow up on items assigned by Medical Device Certification Bodies.

Qualifications:

• Bachelor's degree in pharmaceutical/biomedical/chemistry engineering or science.
• Minimum 3 years working experience in pharmaceutical industry, biomedical industry, healthcare industry or medical device industry.
• Knowledge of Good Distribution Practice for Medical Devices (GDPMD) regulations.
• Certification as a GDPMD Lead Auditor and ISO 13485 may be preferred.
• Minimum 10 audit log as lead auditor per year GDPMD Lead Auditor and ISO 13485 scheme.
• Familiarity with risk management in the context of medical device distribution.
• Strong attention to detail and organizational skills.
• Effective communication skills to convey audit findings and recommendations.
• IRCA certificate preferred.

Training/Skills:

• Interpersonal skills (open-minded, respectful and courteous).
• Leadership and management (organizational, teamwork).
• Professionalism (observant, accurate, detail oriented).
• Language - fluent in verbally, written and reading in English and local languages.
• Ability to effectively communicate and listen with respect in various cultures, environmental, individually or group.
• Observance and vigilance and ability to identify fraudulent activities and practices.
• Able to work under pressure and able to adapt to any changes.
• Prefer person with positive attitude, open minded, have eager to gain more knowledge from different regulatory standard.
• Able to make solid decisions and carry out independent technical judgement.
• Good typing skill required.
• Self-motivator, self-disciplined with the ability to work independently or as a part of a team and able to deliver satisfactory work under limited supervision.