Selected as one of TIME's 25 Best Inventions, the Willow was the first to get rid of the clunky bottles, motors, and cords - and put moms in control. Powerful, comfortable, fully in-bra, and app-connected, our pumps are simply built different. Because you deserve more.• Drive the culture of quality across the organization with the strategic quality plan, adherence of process, while supporting the business objectives.• Develop and sustain the Quality Management System in line with the required regulatory and industry standards (FDA, ISO 13485, ISO 62304, ISO 14791, ISO 60601 and etc.) and business requirements.• Strategize quality improvement activities in collaboration with other departments.• Oversee and lead continuous improvement of Quality Systems, such as Corrective Actions and Preventive Actions (CAPA), deviation, nonconformance, supplier quality (supplier qualification, supplier audit, supplier corrective actions (SCAR)) change management, Internal Audit, External Audit and Inspection Preparation. • Provide training and mentoring to the Quality team members.• Support new and sustaining product development projects as Quality Engineering lead for both hardware and software products.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.• Supported quality engineering needs, coached, and mentored teams to improve quality system management implementation and compliance with quality standards and regulations.• Provided product design review and approval, risk analysis, test method development, and procedures for inspection, testing, and evaluation.• Ensured compliance with ISO 13485, IVDR, and FDA QSR in product development and manufacturing.• Reviewed QC testing results to ensure product specifications compliance.• Managed Complaint Handling, CAPA, and Change Control processes.• Developed Internal Audit Schedule and led internal audits of R&D and MFG labs.

ViewRay®, Inc. (NASDAQ:VRAY) shifts the paradigm in cancer treatment with the MRIdian® MRI-guided adaptive radiotherapy system. We're changing radiation therapy for the better with accurate, precise and personalized cancer treatment that no other system delivers, addressing the key limitations of existing external-beam radiation therapy technologies.• Managed CAPA Review Board (CAB) and facilitated root cause analyses.• Launched new strategic initiatives to close major CAPAs in response to audit findings.• Led and supported internal and external audits, ensuring compliance with regulatory requirements.• Successfully supported the transition of QMS documentation and processes to align with MDSAP and ISO 13485:2016.• Transitioned paper-based QMS to a cloud-based Product Life-Cycle Management platform.• Facilitated and launched over 50 training courses, improving training compliance from 85% to over 95%.

ActivityHero is a marketplace for kids' camps and after school classes. We make it easy to find, compare, and register for the activities your kids love!

Promex, located in Silicon Valley, is an ISO 13485 Medical and ISO 9001 certified microelectronics, semiconductor & advanced packaging and high reliability SMT/PCBA contract assembly service provider for the medical & bioscience, commercial and military markets.• Successfully trained Quality Assurance (QA) and Quality Control (QC) teams on IPC-A-610, achieving a 100% passing rate and full certification for all staff members.• Led the introduction and comprehensive training of the Surface-Mount Technology (STM) and Cleanroom Staff on ISO 13485, ensuring adherence to medical device industry standards.• Conducted internal audit in compliance with ISO 13485 and ISO 9001 standards, identifying and addressing key elements for quality management compliance