job description
Join PERSOL as a Production Section Head in our cutting-edge medical device manufacturing facility in Bali. This leadership role offers a unique opportunity to drive operational excellence, ensuring the highest standards of quality, efficiency, and compliance in a dynamic and fast-paced environment.
As the Production Section Head, you will oversee daily manufacturing operations, lead cross-functional teams, and implement continuous improvement initiatives to meet and exceed KPIs, cost targets, and delivery timelines. Your expertise in medical device production will be instrumental in maintaining regulatory compliance (e.g., ISO 13485, FDA) while fostering a culture of safety, innovation, and lean manufacturing.
This role is ideal for a results-driven professional with a passion for operational leadership in the healthcare sector. If you thrive in a collaborative setting and are committed to delivering life-changing medical products, we invite you to apply and take the next step in your career with a global leader in workforce solutions.
Responsibility
- Lead and supervise production teams to ensure on-time delivery of high-quality medical devices while adhering to GMP and regulatory standards.
- Develop and implement production schedules, optimizing workflows to maximize efficiency and minimize downtime.
- Monitor and analyze KPIs (e.g., OEE, yield rates, defect rates) and drive data-driven improvements to enhance performance.
- Ensure strict compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
- Collaborate with Quality Assurance, R&D, and Supply Chain teams to resolve production issues and implement corrective actions.
- Champion lean manufacturing and Six Sigma methodologies to reduce waste and improve process capabilities.
- Train, mentor, and develop production staff to uphold safety protocols and maintain a high-performance culture.
- Manage budgetary controls for production costs, including labor, materials, and overhead expenses.
Qualifications
- Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical), Manufacturing, or a related field. Advanced degree is a plus.
- Minimum 5+ years of experience in medical device manufacturing, with at least 2 years in a supervisory or managerial role.
- In-depth knowledge of GMP, ISO 13485, and FDA regulations for medical devices.
- Proven track record in process optimization, lean manufacturing, and continuous improvement (e.g., Kaizen, 5S).
- Strong leadership and team management skills with the ability to motivate and develop staff.
- Excellent problem-solving and analytical skills, with proficiency in root cause analysis (RCA) and CAPA systems.
- Familiarity with ERP/MES systems (e.g., SAP, Oracle) and production planning tools.
- Fluent in English; additional language skills (e.g., Indonesian) are advantageous.