About the Company:
Talent Insider is an upcoming HR Consultancy Service, founded in 2021. Our clients have been some of the leading brands in Indonesia, and this service continues to expand.
Registered in Singapore & Indonesia, we can assist with your growth plans and strategies, and continue to expand our regional presence with strong regional partners to assist our client in recruitment and branding strategy.
Job Description:
- Placement will be in Cikarang, West Java.
- Ensure implementation and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, IATF 16949, ISO 17025, HALAL Assurance System, 21 CFR 820, and related regulations.
- Prepare, review, and control quality documents such as SOPs, Work Instructions, DHR, DMR, and Change Control.
- Coordinate internal and external audits, including CAPA follow-up and compliance reporting.
- Manage company certifications (ISO, HALAL, TKDN, etc.) and support product registration processes.
- Monitor quality system performance and collaborate with cross-functional teams to ensure compliance and continuous improvement.
- Lead and monitor daily QA/QMS activities while reporting directly to the QMS Manager.
Job Requirements:
- Bachelor’s degree in Industrial Engineering, Biomedical Engineering, Pharmacy, or related fields.
- Minimum 5 years of experience in QA/QMS within Medical Device, Pharmaceutical, Automotive, or related manufacturing industries.
- Strong knowledge of ISO 13485, ISO 9001, IATF 16949, ISO 17025, CAPA, and regulatory compliance.
- Experienced in handling internal and external audits.
- Good leadership, communication, and coordination skills.
- Fluent in English, both written and spoken
Skils:
Recruiter :
