Lowongan Kerja Jakarta Raya Posisi Medical Device di PT TÜV SÜD INDONESIA

Info Loker

Perusahaan	PT TÜV SÜD INDONESIA
Posisi	Medical Device
Tempat	Jakarta Raya
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Farmasi, Layanan Kesehatan
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

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 industries! 

For example:

• IVD (in-vitro diagnostics) instrumentation and / or reagents

• Active devices: active non-implantable surgical devices (Cryoablation, High frequency surgery, High-frequency generator, High-frequency instruments, ablation generators, suction pumps for blood), standalone software, Active Endoscopes, and etc

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 / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology or relevant 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

• Travelling will be required within ASEAN, with occasional travel to USA and Europe

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Konsultasi (IT, Ilmu Pengetahuan, Teknis & Teknikal)
• Ukuran Perusahaan: 51 - 200 pekerja
• Waktu Proses Lamaran: 29 hari
• Tunjangan dan Lain-lain: Asuransi Gigi, Asuransi kesehatan, Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja), Training