Save Job Back to Search Job Description Summary Similar Jobs A fast-growing U.S.-based startupAt the forefront of medical technology, directly shape groundbreaking innovationAbout Our ClientOur client is an industry pioneer redefining medical imaging and therapeutic technologies, driven by a visionary team committed to making healthcare more accessible and transformative.Job DescriptionEnsure Supplier Compliance: Manage and improve supplier quality systems to meet international medical device standards (ISO 13485, FDA QSR), including conducting audits and driving corrective actions.Supplier Performance Management: Track and evaluate supplier performance using metrics (PPM, SCARs, scorecards), lead root cause analysis, and implement preventive measures for continuous quality improvement.Support New Product Introduction (NPI): Collaborate with cross-functional teams to integrate supplier quality requirements into new product development and manufacturing processes.Product Lifecycle & Documentation Control: Administer the Arena PLM system to manage product documentation, engineering change orders (ECOs), and maintain compliance with regulatory requirements.Continuous Improvement & Compliance: Drive supplier capability development, maintain thorough quality records, and ensure adherence to evolving medical device regulations and company standards.The Successful ApplicantSupplier Quality Experience: 3+ years of experience in supplier quality management, preferably in medical devices, fitness equipment, or related industries.Regulatory Knowledge: Solid understanding of international quality standards and regulations (ISO 13485, ISO 9001, FDA QSR, GMP).Technical & Analytical Skills: Proficient in quality tools and methodologies such as 8D, FMEA, PPAP, CAPA, and root cause analysis.PLM & Documentation Expertise: Hands-on experience with Product Lifecycle Management (PLM) systems, preferably Arena PLM, and strong documentation control skills.Collaboration & Communication: Strong cross-functional teamwork abilities with excellent communication skills in both English and Mandarin; capable of working with global teams and suppliers.What's on OfferDirectly shape groundbreaking innovations and make a global impact.ContactWinnie LanQuote job refJN-062025-6765384Phone number+886 2 8729 8203Job summaryJob functionEngineering & ManufacturingSpecialisationQuality, TechnicalWhat is your area of specialisation?Industrial / ManufacturingLocationTaipei CityContract TypePermanentConsultant nameWinnie LanConsultant phone+886 2 8729 8203Job ReferenceJN-062025-6765384
