job description
Join Global Promedicals Service and take the next step in your career within the dynamic healthcare industry. As a Qualified Compliance Tester (Conformity Assessment Technician), you will play a pivotal role in ensuring that medical devices, equipment, and products meet stringent regulatory standards and quality benchmarks.
This is a unique opportunity to work in a fast-growing sector with a company that values excellence, innovation, and professional development. Enjoy a competitive salary, comprehensive benefits package, and ongoing training programs designed to enhance your expertise and career progression.
Based in Bali, you’ll collaborate with a team of industry experts to deliver high-impact solutions that drive compliance and safety in healthcare. If you are detail-oriented, technically skilled, and passionate about quality assurance, we want to hear from you!
Responsibility
- Conduct thorough conformity assessment testing on medical devices and healthcare products to ensure compliance with national and international standards (e.g., ISO, FDA, CE).
- Perform calibration, validation, and verification of testing equipment to maintain accuracy and reliability.
- Document and analyze test results, preparing detailed technical reports for regulatory submissions and internal reviews.
- Collaborate with cross-functional teams, including R&D, production, and quality assurance, to address non-conformities and implement corrective actions.
- Stay updated on emerging regulations, industry trends, and testing methodologies to ensure alignment with best practices.
- Assist in the development and revision of standard operating procedures (SOPs) for testing protocols.
- Provide technical support and guidance to junior staff and stakeholders on compliance-related matters.
- Participate in audits and inspections by regulatory bodies, ensuring all processes adhere to required standards.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field.
- Minimum 2 years of experience in conformity assessment, quality control, or testing within the healthcare or medical device industry.
- Strong knowledge of regulatory standards (e.g., ISO 13485, ISO 9001, FDA 21 CFR, EU MDR).
- Proficiency in using testing equipment, calibration tools, and data analysis software.
- Excellent attention to detail and ability to interpret complex technical documentation.
- Familiarity with risk management processes (e.g., ISO 14971) and root cause analysis (RCA).
- Strong communication and teamwork skills, with the ability to work in a multicultural environment.
- Certification in quality assurance (e.g., CQA, Six Sigma) is a plus.