job description
Join PERSOL as a Validation Engineer (Mandarin Speaker) in the thriving medical device and consumables manufacturing sector in Badung, Bali. This is a unique opportunity to oversee critical validation activities within an ISO 13485-compliant facility, ensuring the highest standards of quality and compliance for life-saving medical products.
As a key member of our engineering team, you will play a pivotal role in maintaining regulatory compliance, optimizing validation processes, and driving continuous improvement in our manufacturing operations. Your expertise in validation protocols and fluency in Mandarin will enable seamless collaboration with international stakeholders, ensuring alignment with global quality standards.
If you are a detail-oriented professional with a passion for quality assurance and a desire to contribute to the healthcare industry, we invite you to apply for this impactful role in one of Bali’s most dynamic industrial hubs.
Responsibility
- Develop, execute, and document validation protocols (IQ, OQ, PQ) for medical device and consumable manufacturing processes in accordance with ISO 13485 and other regulatory requirements.
- Conduct risk assessments and gap analyses to identify areas for improvement in validation processes and ensure compliance with industry standards.
- Collaborate with cross-functional teams, including R&D, production, and quality assurance, to implement validation strategies and resolve non-conformities.
- Prepare and review validation reports, ensuring accuracy, completeness, and adherence to regulatory guidelines.
- Liaise with internal and external auditors, providing technical support during inspections and addressing findings promptly.
- Maintain up-to-date knowledge of global regulatory requirements (e.g., FDA, EU MDR) and industry best practices for medical device validation.
- Train and mentor junior staff on validation methodologies, tools, and documentation standards.
- Utilize Mandarin language skills to communicate with suppliers, clients, and regulatory bodies in Mandarin-speaking regions.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related field. Advanced degrees are a plus.
- Minimum 3-5 years of experience in validation engineering within the medical device, pharmaceutical, or consumable manufacturing industry.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements for medical device validation.
- Proven experience in developing and executing IQ/OQ/PQ protocols and writing validation reports.
- Fluency in Mandarin (written and spoken) is mandatory; proficiency in English is required.
- Strong analytical, problem-solving, and project management skills with the ability to manage multiple priorities.
- Familiarity with validation software tools (e.g., MasterControl, TrackWise, or SAP) is advantageous.
- Excellent communication and interpersonal skills to collaborate effectively with global teams.