Diploma or Bachelor’s Degree in Industrial Engineering, Biomedical Engineering, Biomedical Science, Pharmacy, or equivalent
ExperienceMinimum 3 years experience in the area of Quality System (QMS) and Regulatory administrations in medical device industry
Technical KnowledgeStrong understanding of maintaining QMS based on CPAKB, ISO 13485, ISO 9001, HALAL, and relevant medical devices standards and regulations (FDA CFR, Japan MHLW, EU MDR). Having knowledge in Data Integrity, Data Governance and CSV is a plus
SkillsDetail-oriented with excellent analytical thinking & problem solving skills
Active and fluent in English (both oral & written) is a must
Demonstrated effective communication, project management & leadership skills
Proficient in using Microsoft Office suites (including Outlook, Teams, OneDrive, Sharepoint)
Job Description- Oversee and control the implementation of the Quality Management System in accordance with applicable standards and regulations, specifically regarding quality-related documentation and activities within PT PHC Indonesia.
- Monitor and ensure compliance of quality activities at PT PHC Indonesia with established regulatory standards, including post‑audit follow ups to relevant departments.
- Manage the process for obtaining and maintaining business permits and licenses necessary for PHCI's business needs, including CPAKB, ISO, Halal and regulatory reporting (FDA, MOH & BPJPH)
- Track, communicate, and update relevant departments and management on changes to quality standards and regulations.
- 1991 : Established as PT Kotobuki Electronics Indonesia (KEI)
- 1998 : Name changed to PT Matsushita Kotobuki Electronics Indonesia (MKI)
- 2005 : Name changed to PT Panasonic Shikoku Electronics Indonesia (PSECI)
- 2011 : Name changed to PT Panasonic Healthcare Indonesia (PHCI)
- 2018 : Name changed to PT PHC Indonesia (PHCI)
- At its inception PT PHC Indonesia produced Audio Video products, 1991~2011 (VCR, Combi, CD‑Rom, C‑Movie, HA‑Mieta, MMD, PDP Power, etc).
- Furthermore, in 2011~present, PT PHC Indonesia produces healthcare products (Hearing Instrument, Glucose Monitoring System, Medical LCD Monitor, Ultrasound, Dental Intra Oral Camera, Medical Refrigerator, Incubator, Ventilator, etc).
- Oriented to improve health around the world, and play new technology in healthcare product.
- To maintain company credibility, we apply international standard certificates, such as ISO13485, ISO9001, ISO14001, ISO45001, IATF16949, Halal Certificate, etc.
- The company needs people like you who will work in a dynamic space for challenge, growth and innovation, to participate in developing and delivering health solutions that can help millions of people.
- Medical
- Miscellaneous allowance
- Loans
- Sports (e.g. Gym)
- Parking
- Vision