Senior Manufacturing Engineer / QMS Engineer (Plastics Injection Moulding) - Medical Devices Sector

RecruitPedia Pte Ltd · 📍 Badung, Bali, Indonesia · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
USD 5500 - 6500
We are seeking a highly experienced Senior Manufacturing Engineer or QMS Engineer with expertise in plastics injection moulding for the medical devices sector. The ideal candidate will have a strong background in process optimization, quality management systems, and regulatory compliance. This role offers an exciting opportunity to work in a dynamic environment and contribute to the production of high-quality medical devices.

📋 Tanggung Jawab Pekerjaan

Develop and implement manufacturing processes for plastics injection moulding to ensure product quality and efficiency.,Conduct process optimization and troubleshooting to improve production output and reduce waste.,Develop and maintain quality management systems (QMS) in compliance with ISO 13485 and other relevant standards.,Lead and mentor a team of engineers and technicians to ensure adherence to quality standards and regulatory requirements.,Conduct root cause analysis and implement corrective and preventive actions to address quality issues.,Collaborate with design and engineering teams to ensure that manufacturing processes are feasible and efficient.,Monitor and report on key performance indicators (KPIs) related to production, quality, and regulatory compliance.,Stay updated with industry trends and best practices in plastics injection moulding and quality management.

🎓 Kualifikasi & Syarat

Bachelor's degree in Mechanical Engineering, Industrial Engineering, or related field.,Minimum of 5 years of experience in manufacturing engineering, particularly in plastics injection moulding.,Proven experience in developing and implementing QMS in compliance with ISO 13485 and other relevant standards.,Strong knowledge of regulatory requirements for medical devices, including FDA, CE, and ISO standards.,Proficiency in using manufacturing execution systems (MES) and quality management software.,Excellent problem-solving and analytical skills with the ability to conduct root cause analysis.,Strong leadership and team management skills.,Fluency in English, both written and spoken.

🛠️ Keahlian

Process optimization and troubleshootingQuality management systems (QMS)Regulatory compliance (ISO 13485FDACE)Manufacturing execution systems (MES)Root cause analysisTeam leadership and mentoringIndustry knowledge in plastics injection mouldingLanguage skills (English)
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