MHS Lead Auditor ISO 13485

TÜV SÜD – A global leader in the field of testing, inspection, management system certification and product certification renowned for quality, integrity and technical excellence.

Established more than 150 years ago in Germany, TÜV SÜD is a leading global provider of technical services with more than 28,000 highly skilled employees across 1,000 offices worldwide. TÜV SÜD offers a wide range of testing & product certification, inspection, auditing & system certification, training and knowledge services. We are a premium quality, safety, and sustainability solutions provider.

MEDICAL DEVICE (REGULATORY SYSTEMS) AUDITOR

(MEDICAL & HEALTH SERVICE)

We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices – including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and other QMS certification scheme, where applicable. We welcome experts from different medical device and IVD industries!

Key Responsibilities

• Perform onsite audits at manufacturer’s premises by evaluating their Quality Management Systems in accordance with the requirements of the MDR / IVDR, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
• Assist Sales personnel by providing technical advice to existing and prospective clients
• Deal with clients’ queries relating to certification process including application reviews within acceptable time frames as a project manager
• Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission
  
  

Key Requirements

• Bachelor’s degree in Electrical / Software / Medical Engineering, Biomedical Science, Chemical Engineering, or relevant equivalent Sciences
• Have minimum 4 years of relevant experience in testing of medical device / design and development activities / process validation / application of process technology / service & maintenance in the medical device industry.
• Have at least 2 years’ experience in Quality Management Systems environment
• Clear and articulate presentation ability with excellent communication skills
  
  

We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD.

Work Area: Medical Devices & Healthcare

Country/Region: Philippines

Job Location: Pasig City

Working Model : Field Work

Employment Type: Full time / regular

Company: TÜV SÜD PSB Philippines

Org Unit Code: PO1

Requisition ID: 1651

---