Lead Auditor - Medical Devices (Urgent Hiring)

Medivice Certification Sdn Bhd; Selangor; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical certification firm in Malaysia is urgently hiring a Lead Auditor for Medical Devices. The successful candidate will conduct audits and training, manage clients, and lead audit teams. They must possess a degree in a relevant scientific field and be registered with the Medical Device Authority as an Auditor. A minimum of 5 years of experience in R&D or QA is required, along with knowledge of medical device regulatory requirements and strong communication skills.

Qualifications

• Registered with Medical Device Authority (MDA) as Auditor.
• Minimum 5 years of full-time working experience in R&D and/or QA in relevant industries.
• Knowledge of relevant Medical Device Regulatory requirements is mandatory.

Responsibilities

• Conduct audits and training in accordance with medical device requirements.
• Lead audit teams during initial and surveillance audits professionally.
• Provide market information on new market trends and business opportunities.

Skills

Communication skills

Negotiation skills

Interpersonal skills

Independent work

Initiative

Resourcefulness

Education

Degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical, Electronics, Electrical or Mechanical Engineering

Job description

Lead Auditor - Medical Devices (Urgent Hiring)

We are seeking a Lead Auditor (Medical Devices) to join our dynamic, enthusiastic and expanding team. The role will involve:

Conduct audits and training in accordance with medical device requirements, including but not limited to ISO 13485, GDPMD, Conformity Assessment by Way of Verification and Full Conformity Assessment.

Client management and promotion of Medivice Certification Sdn Bhd services.

Lead audit teams during initial and surveillance audits and conduct audits in a professional manner.

Ensure Medivice Certification Sdn Bhd procedures are followed for relevant products under their area of expertise.

Provide market information to management on new market trends and business opportunities.

Apply sound judgement and act in accordance with Medivice Certification Sdn Bhd standards of ethics and integrity.

Carry out customized audits as required by Management.

Conduct training course under their specialty.

Perform any additional tasks as required by Management.

REQUIREMENTS:

Degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical, Electronics, Electrical or Mechanical Engineering.

Registered with Medical Device Authority (MDA) as Auditor

Minimum 5 years of full-time working experience in R&D and/or QA in relevant industries.

Preferably has attended ISO 13485 and ISO 9001 Lead Auditor course and has auditing experience

Knowledge of relevant Medical Device Regulatory requirements is mandatory.

Good communication skills, negotiation and interpersonal skills.

Capable of working independently with a high level of initiative and resourcefulness.

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