job description
Join PT Jayamas Medica Industri, a pioneer in medical manufacturing, as we expand our operations to Bali. We are seeking a dynamic and experienced Quality Control (QC) Manager to lead our commitment to excellence in product safety, compliance, and innovation.
In this pivotal role, you will oversee all QC processes, ensuring our medical products meet the highest international standards (ISO, GMP, FDA). Your leadership will drive continuous improvement, team development, and regulatory adherence, positioning our company as a trusted name in the healthcare industry.
Based in the vibrant and strategic location of Bali, this opportunity offers a competitive salary, professional growth, and the chance to make a tangible impact in the medical field. If you are passionate about quality assurance and eager to contribute to life-saving products, we invite you to join our mission.
Responsibility
- Develop, implement, and maintain QC policies, procedures, and documentation in compliance with ISO 13485, GMP, and other regulatory standards.
- Lead and supervise the QC team, ensuring efficient testing, inspection, and validation of raw materials and finished medical products.
- Conduct root cause analysis for non-conformities and implement corrective/preventive actions (CAPA) to mitigate risks.
- Collaborate with R&D, production, and supply chain teams to ensure seamless integration of quality standards across all stages.
- Oversee calibration and maintenance of QC equipment, ensuring accuracy and reliability of test results.
- Prepare and submit regulatory reports, audit responses, and certification documentation to local and international authorities.
- Drive continuous improvement initiatives (e.g., Lean, Six Sigma) to enhance product quality and operational efficiency.
- Train and mentor QC staff on best practices, technical skills, and compliance requirements.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biomedical Engineering, or a related field. Master’s degree is a plus.
- Minimum 5 years of experience in QC management within the medical device, pharmaceutical, or healthcare manufacturing industry.
- In-depth knowledge of ISO 13485, GMP, FDA 21 CFR Part 820, and other relevant quality standards.
- Proven leadership in managing QC teams, with strong analytical and problem-solving skills.
- Experience with laboratory information management systems (LIMS) and statistical process control (SPC).
- Excellent communication skills in English and Indonesian, with the ability to prepare technical reports.
- Certifications in Quality Management (e.g., ASQ CQA, IRCA Lead Auditor) are highly advantageous.
- Willingness to relocate to Bali or commute as required.