Orchid Thu

Staff Product Quality Engineer with 15+ years of experience in medical device, pharmaceutical, and semiconductor manufacturing environments. Proven expertise in ISO 13485, FDA compliance, CAPA, process validation, NPI, and continuous improvement. Demonstrated success in reducing defects, leading cross-functional teams, and driving operational excellence in highly regulated manufacturing environments.

Recently completed an MSc in International Business Management at Liverpool John Moores University (dissertation submitted).

Staff Product Quality Engineer at ThermoFisher Scientific (2012-01 – 2024-12)

• Ensured compliance with ISO 13485, FDA 21 CFR Part 820, cGMP, and QMS requirements.
• Managed New Product Introduction (NPI), process validation (IQ/OQ/PQ), and product lifecycle quality activities.
• Directed root cause investigations and implemented corrective and preventive actions to resolve quality issues, improving manufacturing reliability.
• Reduced manufacturing defects by 20% across global manufacturing sites through process improvement initiatives.
• Drove Lean Manufacturing, Six Sigma, and continuous improvement initiatives to enhance efficiency, quality, and operational performance.
• Conducted Design and Process FMEA to identify, assess, and mitigate product and process risks.
• Utilized quality metrics and data analysis to identify trends, support decision-making, and drive sustainable process improvements.
• Collaborated with R&D, Operations, Supply Chain, and Regulatory Affairs teams to improve product quality and accelerate commercialization.
• Provided quality leadership for global product launches and manufacturing transfers.
• Supported post-market surveillance (PMS), complaint investigations, trend analyses, and regulatory reporting.
• Supported regulatory submissions and change control processes, ensuring compliance with industry standards in collaboration with Regulatory Affairs.
• Supported successful external audits and inspections, maintaining regulatory compliance and audit readiness.
• Led team of 10 engineers, enhancing technical skills and improving project outcomes.

Senior Manufacturing Engineer at Benchmark Electronics (2010-01 – 2012-12)

• Delivered approximately S$ 900,000 annual cost savings through manufacturing process improvement and operational optimization.
• Utilized data-driven problem-solving and root cause analysis to effectively resolve production and quality issues, contributing to overall operational stability.
• Facilitated production planning, KPI monitoring, and resource allocation, ensuring alignment with operational targets and improving delivery performance.
• Engaged with cross-functional teams to drive enhancements in manufacturing performance and foster a culture of continuous improvement.

Plant Engineer at UMS Semiconductor Pte Ltd (2006-01 – 2010-12)

• Managed engineering projects to optimize production processes, enhancing overall operational efficiency.
• Developed and implemented preventive maintenance (PM) to improve equipment uptime and operational stability.
• Provided analytical insights to improve manufacturing performance.
• Coordinated planning and workflow activities to ensure timely and budget-compliant project delivery.
• Collaborated with quality and supplier teams to align engineering and operations with product requirements.

MSc in International Business Management – Liverpool John Moores University (LJMU) (2026-08)

MSc in Environmental Engineering – National University of Singapore (NUS)

BSc in Industrial Chemistry – University of Yangon