job description
Join RecruitPedia Pte Ltd as a QC Chemist (Medical Devices) in the vibrant region of Badung, Bali. This is a unique opportunity for a detail-oriented Quality Control Chemist to ensure the highest standards of medical device manufacturing, combining scientific expertise with regulatory compliance in a dynamic, international environment.
In this role, you will play a pivotal part in maintaining product integrity, safety, and efficacy through rigorous testing, documentation, and adherence to global quality standards. Your work will directly contribute to the delivery of life-enhancing medical devices, making a tangible impact on patient care worldwide.
Ideal for professionals with a Chemistry background and a passion for precision, this position offers a competitive salary, career growth, and the chance to work in one of Indonesia’s most innovative and scenic locations.
Responsibility
- Conduct comprehensive chemical and physical testing of raw materials, in-process samples, and finished medical devices to ensure compliance with specifications.
- Perform qualitative and quantitative analyses using advanced laboratory techniques such as HPLC, GC, UV-Vis, and wet chemistry methods.
- Document and review test results, deviations, and investigations in accordance with GMP, ISO 13485, and FDA 21 CFR regulations.
- Collaborate with cross-functional teams (R&D, Production, Regulatory) to resolve quality issues and implement corrective actions.
- Calibrate, maintain, and troubleshoot laboratory equipment to ensure accuracy and reliability of test data.
- Develop and validate new test methods or improve existing protocols to enhance efficiency and compliance.
- Participate in internal and external audits, ensuring adherence to quality management systems (QMS).
- Stay updated on industry trends, regulatory changes, and emerging technologies in medical device QC.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Minimum 3 years of experience in Quality Control within the medical device, pharmaceutical, or biotech industry.
- Hands-on experience with analytical instruments (HPLC, GC, Spectroscopy) and laboratory information management systems (LIMS).
- Strong knowledge of GMP, ISO 13485, FDA, and CE marking requirements for medical devices.
- Excellent attention to detail, problem-solving skills, and the ability to interpret complex data.
- Proficient in Microsoft Office and statistical analysis tools (e.g., Minitab, JMP).
- Fluency in English (written and verbal); additional languages are a plus.
- Ability to work independently and in a team, with strong communication and documentation skills.