Skill diminta
DockerLinuxTroubleshooting
Deskripsi
Deskripsi pekerjaan IT Development PT NRI Global Mandiri (Nature Republic Indonesia)
JOB DESCRIPTION
- Responsible for the technical aspects of medical devices
- Ensure compliance with medical device regulations & licensing
- Supervise installation, function testing, calibration & maintenance.
- Handle technical complaints & corrective/preventive actions.
- Draft & review technical documents (SOPs, manuals, reports).
- Act as the technical PIC for audits, inspections, & licensing.
- Provide technical support & training.
QUALIFICATIONS
• Educational background
- Diploma (D3) or Bachelor's Degree (S1) in Pharmacy or Pharmacist Professional Degree;
- Bachelor's Degree (S1) in Biomedical Engineering;
- Diploma (D3)/Bachelor's Degree (S1) in Informatics Engineering (specifically for medical device software). Preferred
- Minimum 1-2 years of experience in the medical device field.
- Possess a Good Distribution Practice (GDP/CDB) training certificate for Medical Devices for Technical Persons in Charge from the Ministry of Health.
- Understand regulations, IDAK, and the CDAKB (Good Distribution Practice for Medical Devices) quality system.
- Familiar with medical device standards such as ISO 13485, ISO 14971, and CSDT (Common Submission Dossier Template) documents for AKL (imported medical device) registration purposes at the Ministry of Health.
- Have a solid understanding of software validation (IEC 62304) for SaMD/SiMD, or sterilization processes and biocompatibility for sterile non-electromedical devices.
- Willing to be registered as a PJT in OSS/Ministry of Health (Kemenkes).
- Detail-oriented, responsible, & communicative.
- Technical Skills Required
- OS: Proficient in Linux (Ubuntu Desktop installation & configuration).
- Linux CLI: Strong command-line basics.
- Docker: Experienced with Docker CLI.
- Docker Compose: Ability to manage multi-container applications
- Networking: Basic network troubleshooting.
PARTTIME ARE WELCOME