Qa & Medical Device Technical In Charge (Pjt)

Position : QA & Medical Device Technical in Charge (PJT)

Location : Jakarta

Role Summary & Responsibility :

• Lead the site internal audit program and support global/regions audit for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety
• Support continuous improvement activities regarding areas of responsibility
• Support CAPA system through record ownership where appropriate.
• Coaching and mentoring functional teams on the development, maintenance and simplification of local procedures.
• Develop basic and advanced training programs for CDAKB, and assure training of CDAKB implementation to all related personnel
• Support QMS and Bowler KPIs and business operating rigor with actionable data and analysis
• Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility
• Prepare site for external audits and implement corrective actions to address non-conformities.
• Implement quality management system as stipulated in CDAKB
• Hold the role of Technical Responsible Person (PJT - Penanggungjawab Teknis) of Company and registered on IDAK License as PJT
• Perform roles and responsibilities of PJT based on the Indonesia MoH Regulation
• Analyze & communicate proposed, new or changing QA requirements & devise strategies for their implementation, ensuring business goals are met
• Engage stakeholders and proactively communicate QA priorities & potential risks to business leads
• Understand clearly all the 13 aspects about CDAKB (Cara Distribusi Alat Kesehatan yang Baik) and its application, knowledge of laws and regulations regarding the distribution of AlKes and their application.
• Collect, summarize & evaluate performance metrics to identify QA weaknesses & drive improvements in procedures or oversight

Requirements :

• Ability to prioritize, plan & evaluate deliverables to established strategic goals
• Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
• Proven track record in performing external and internal audits (ISO13485/CDAKB)
• Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
• Minimum Bachelor’s Degree Pharmacy or Biomedical Engineering
• Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulated environment
• Have experience as PJT in a Medical Device Company, Minimum 2 years or minimum of 3 years progressive Quality Management Systems.