job description
Join Global Promedicals Service as a Qualified Compliance Tester and play a pivotal role in ensuring the safety and efficacy of medical devices and healthcare products. This is your opportunity to advance your career in the thriving healthcare industry, where you'll benefit from competitive compensation, comprehensive benefits, and continuous professional development.
Based in the vibrant regions of Bali, including Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, and Badung, you'll work in a dynamic environment that values precision, compliance, and innovation. Your expertise will directly impact public health by verifying that products meet rigorous regulatory standards.
If you are detail-oriented, technically skilled, and passionate about quality assurance, we invite you to apply and become part of a team that is shaping the future of healthcare compliance.
Responsibility
- Conduct thorough compliance testing on medical devices and healthcare products to ensure adherence to local and international regulations.
- Perform detailed inspections, measurements, and functional tests using specialized equipment and methodologies.
- Document test procedures, results, and deviations in compliance with company and regulatory standards.
- Collaborate with cross-functional teams, including engineers and quality assurance specialists, to address non-compliance issues.
- Maintain accurate records of testing activities and prepare comprehensive reports for regulatory submissions.
- Stay updated on industry regulations, testing protocols, and technological advancements in medical device compliance.
- Participate in internal and external audits to ensure continuous improvement in testing processes.
- Provide technical guidance and training to junior staff on compliance testing procedures.
Qualifications
- Bachelor’s degree in Engineering, Biomedical Sciences, or a related technical field.
- Minimum of 2 years of experience in compliance testing, quality control, or a similar role within the healthcare or medical device industry.
- Strong understanding of regulatory standards such as ISO 13485, FDA, or CE marking requirements.
- Proficiency in using testing equipment and software relevant to medical device compliance.
- Excellent analytical and problem-solving skills with a keen attention to detail.
- Ability to interpret technical drawings, specifications, and regulatory documentation.
- Strong communication skills in both English and Indonesian, with the ability to write clear and concise reports.
- Certification in quality management or compliance testing is a plus.