job description
Join a fast-growing Medical Device Manufacturer in Bali, Indonesia, as a Production Manager specializing in Injection Molding and ISO 13485 compliance. This is a unique opportunity to lead high-standard production and quality systems in a dynamic, international environment.
As part of our team, you will oversee the manufacturing of medical devices, ensuring adherence to strict regulatory standards while driving operational excellence. With a focus on career growth and professional development, this role offers the chance to work alongside a diverse, skilled team in one of the most innovative sectors of healthcare.
Bali’s vibrant expat community and strategic location make it an ideal place for professionals seeking both career advancement and a high quality of life. If you are a results-driven leader with expertise in medical device manufacturing, we invite you to apply and take the next step in your career.
Responsibility
- Oversee daily production operations for injection molding of medical devices, ensuring efficiency and compliance with ISO 13485 standards.
- Implement and maintain quality management systems to meet regulatory and customer requirements.
- Lead, train, and mentor production teams to achieve operational excellence and continuous improvement.
- Monitor and optimize production processes to reduce waste, improve yield, and enhance product quality.
- Collaborate with cross-functional teams (R&D, Quality Assurance, Supply Chain) to ensure seamless product development and delivery.
- Develop and enforce SOP (Standard Operating Procedures) and work instructions for production staff.
- Conduct regular audits and risk assessments to ensure compliance with GMP (Good Manufacturing Practices) and other industry regulations.
- Drive cost-saving initiatives without compromising product quality or safety.
Qualifications
- Bachelor’s degree in Engineering, Manufacturing, or a related field; Master’s degree is a plus.
- Minimum 5+ years of experience in production management within the medical device or pharmaceutical industry.
- Proven expertise in injection molding processes and ISO 13485 compliance.
- Strong knowledge of GMP, FDA, and other regulatory standards for medical devices.
- Excellent leadership and team management skills with a track record of improving operational efficiency.
- Proficiency in Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
- Familiarity with ERP/MRP systems and production planning tools.
- Fluent in English; additional languages are a plus.