Principal Supplier Quality Engineer

2 weeks ago


Singapore Danaher Life Sciences Full time

Overview The Principal Supplier Quality Engineer role at Danaher Life Sciences ensures the quality and reliability of supplied components through strategic supplier collaboration and risk-based oversight. This on-site position reports to the Senior Manager, Supplier Quality and is part of the Regulatory Affairs and Quality Assurance department located in Singapore. In This Role, You Will Have The Opportunity To: Join Leica Microsystems, a Danaher operating company, and contribute to scientific discoveries and patient outcomes by applying Danaher’s system of continuous improvement while delivering high-quality components to support life sciences, diagnostics, and biotechnology. Responsibilities Supplier Qualification and Lifecycle Oversight – Qualify and approve direct and indirect suppliers of critical components/special processes to ensure consistent, compliant output. Maintain supplier status through rigorous quality system assessments, performance monitoring, and targeted corrective actions. Evaluate and approve supplier-initiated changes to safeguard conformance with specifications, customer expectations, and applicable regulatory standards. Conduct risk-based routine audits to verify adherence to contractual, customer, and regulatory requirements—driving sustained quality and reliability across the supply base. Supplier Issue Resolution and Continuous Improvement – Lead on-site containment and resolution of complex nonconformances and escapes, applying structured problem-solving (e.g., RCA/5-Why/Fishbone) and implementing effective corrective and preventive actions. Exercise sound judgment using multiple data sources, operating with high independence and accountability. Facilitate cross-functional teams (Quality, Operations, Engineering, Procurement) to remove root causes and drive measurable improvements in defect rate, rework, and OTD impact. FAI/MRB Leadership, Audit Representation & Quality Reporting – Lead and govern the First Article Inspection (FAI) and Material Review Board (MRB) processes, ensuring timely execution, compliance, and effective disposition of nonconforming material. Represent the team during external and third-party audits or inspections, addressing inquiries related to supplier management, FAI, and MRB. Establish and standardize inspection methods, procedures, gauges, and measurement systems (e.g., MSA/GR&R) with suppliers. Provide clear reporting on supplier performance, quality trends, and systemic risks to management. Leadership and Technical Guidance – Representing Supplier Quality Engineering (SQE) in cross-functional forums, aligning initiatives with organizational goals, and mentoring SQEs on quality practice, technical problem-solving, and accountability. Govern critical quality activities, including engineering change impact/risk assessment, control plan reviews, customer complaint reviews, CAPA effectiveness, and inventory containment/traceability; ensure timely communication to suppliers and durable, long-term effectiveness of actions. Operational Excellence and Compliance – Stay current with Danaher Business System (DBS) tools such as 5S, DMP, SW, and TPI to promote sustainable continuous improvement. Ensure departmental compliance with the Quality Management System and Environment, Health & Safety (EHS) requirements, and address EHS concerns raised by associates. Essential Requirements Degree in relevant Engineering discipline with 7 years of relevant working experience or Diploma in relevant Engineering discipline with 10 years of relevant working experience. Experience in supplier quality engineering within an assembly operations or engineering environment. Strong knowledge in various statistical control methods and in QMS 9001. Familiar with ISO13485, USFDA QSR/cGMP (21 CFR Part 820) and ISO14971 for medical devices. Good understanding of metrology, inspection methods, equipment and engineering drawings. Knowledge of measurement techniques. Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs. Check out our benefits at Danaher Benefits Info. Join our winning team today. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance For more job opportunities in Singapore, Singapore, and surrounding regions, refer to the job listings on the company site. #J-18808-Ljbffr



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