job description
Join PERSOL, a global leader in workforce solutions, as a Manufacturing Engineer (Mandarin Speaker) in the vibrant and growing tech hub of Bali, Indonesia. This is an exceptional opportunity to contribute to the production of medical-grade consumables under ISO 13485 standards, ensuring the highest levels of quality and compliance in a dynamic manufacturing environment.
In this role, you will play a pivotal part in optimizing production processes, driving efficiency, and maintaining the stringent quality standards required for medical devices. Your expertise will directly impact the success of our operations, making this a highly rewarding position for a detail-oriented and proactive professional. As a Mandarin speaker, you will also bridge communication gaps between international teams, ensuring seamless collaboration and execution.
Bali offers a unique blend of professional growth and an unparalleled lifestyle, with its rich culture, stunning landscapes, and thriving expat community. Whether you're based in Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, or Badung, you'll enjoy a work-life balance that is second to none. If you are passionate about manufacturing excellence and eager to advance your career in a supportive and innovative environment, we want to hear from you!
Responsibility
- Design, implement, and optimize manufacturing processes for medical-grade consumables to ensure compliance with ISO 13485 and other regulatory standards.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to drive continuous improvement in production efficiency and product quality.
- Develop and maintain process documentation, including standard operating procedures (SOPs), work instructions, and process flow diagrams.
- Troubleshoot and resolve manufacturing issues, identifying root causes and implementing corrective actions to minimize downtime and defects.
- Lead process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Monitor key performance indicators (KPIs) such as yield, cycle time, and scrap rates to drive operational excellence.
- Facilitate communication between international teams as a Mandarin speaker, ensuring clear and effective collaboration with stakeholders in China and other regions.
- Support new product introductions (NPI) by providing manufacturing expertise and ensuring smooth transitions from development to production.
Qualifications
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
- Minimum of 3-5 years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industry.
- Proficiency in Mandarin (both written and verbal) is essential for this role.
- Strong knowledge of ISO 13485, GMP, and other regulatory standards for medical device manufacturing.
- Experience with process validation, lean manufacturing, and Six Sigma methodologies is highly desirable.
- Hands-on experience with CAD software, ERP systems, and MES (Manufacturing Execution Systems).
- Excellent problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment.
- Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and stakeholders.