Sukarsaatmadja

About Sukarsaatmadja

I build quality systems that turn compliance from a cost center into a competitive advantage.Over 12+ years leading quality and regulatory functions across healthcare technology, connected devices, and engineered products, I\'ve architected QMS programs, taken organizations through ISO 9001:2015 certification, and built the audit, CAPA, and supplier quality muscle that lets product teams ship faster. What I bring:→ Quality Management Systems at scale. Led multi-site ISO 9001:2015 QMS implementations from gap analysis through certification readiness, including current company-wide adoption.→ Measurable bottom-line impact. Delivered a 30% reduction in Cost of Poor Quality — $500K in annual savings — through structured root cause analysis and corrective action programs. Cut recurring process deviations by 50% by deploying RCA, PDCA, and PSR fault-handling tools.→ Supplier quality and supply-chain risk reduction. Built supplier audit, qualification, and corrective action programs that lifted compliance rates and de-risked procurement across diversified supply chains.→ Cross-functional leadership. Translate regulatory and quality requirements into engineering, operations, and supply chain reality. Trusted liaison between external auditors, regulatory bodies, and internal stakeholders.→ Workforce capability building. Stood up training programs on QMS, CAPA, and quality tools that drove consistent adoption across cross-functional teams and shifted organizational culture toward data-driven decision-making.Industries: Healthcare technology / RTLS, ruggedized electronics, advanced materials for energy, oil and gas

Experience

1. Sr Manager, Quality Assurance & Regulatory Affairs

   CenTrak

   May 2023 — Present

   Lead company-wide ISO 9001:2015 QMS adoption — owning gap analysis against standard requirements, framework design, process documentation, and internal audit readiness toward certification- Drive CAPA and root cause analysis programs for product quality, process deviations, and supplier non-conformances, with closure verification protocols that hold the system accountable- Built the supplier quality function — audits, qualification, corrective action requests, non-conforming material disposition, and a supplier diversification program that reduced procurement risk- Established engineering process controls for new product development and engineering change, ensuring design integrity and traceability across the product lifecycle- Lead the finished goods inspection team and redesigned inspection processes to reduce escapes and improve first-pass yield- Own the Return Merchandise Authorization (RMA) and warranty return process — channeling field quality data back into the corrective action pipeline so customer signal loops into design and manufacturing- Serve as primary quality liaison between external partners and internal Engineering, Operations, Product Management, and Supply Chain- Establish, monitor, and report quality KPIs, surfacing trends and improvement opportunities to leadership- Manage the electronic document management system, maintaining controlled procedures and technical documentation.

Education

• MIT Professional Education

  Sustainability

• Mercer County Community College

  Certificate, Clinical Development and Regulatory Affairs

  2019 — 2019

• The University of Electro-Communications, Japan

  One Year Exchange Study Program , Science and Engineering

• The University of Tokyo

  Master of Engineering (M.Eng.), Polymer Chemistry

  2007 — 2009

• Institut Teknologi Bandung

  Bachelor of Science (B.Sc.), Chemistry

  2000 — 2005