Hiring: Senior Quality Operations Manager-Advanced Imaging Company: Philips Location: Bedford, MA Job Posted Time: 2026-09-10 10:28:42 Employment Type: Full-time Target Skills & Keywords : R About the job Experience: •10+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality operations, audit support, process validation/improvement, CAPA, non-conformance, PFMEA’s and Change/Risk Management (ISO 14971). •3+ years’ proven experience managing quality teams- budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc. Required Skills: •Responsible for overseeing strategic process validation initiatives, driving targeted/continuous improvements to optimize product quality /manufacturing efficiency, managing CAPA/Nonconformance processes and ensuring compliance with regulatory standards and operational excellence. •Manages talent across the Quality team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management. •Manages the Corrective and Preventive Actions (CAPA) process rigorously, investigating nonconformances, determining root causes, and implementing robust corrective and preventive actions, while monitoring CAPA effectiveness and overseeing the management of Non-Conformances (NC) and Quality Notifications (QN). •Plans the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. •Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and uphold superior quality benchmarks. •Possesses complete knowledge of products/services, often leads a cooperative effort among project team members, and frequently interacts with subordinates, supervisors, customers, and functional peer groups on matters between functional areas. •Drives resolution of quality non-conformities with Philips internal suppliers and drives process validation as local factory-level QMS process owner to ensure adherence to quality standards and regulatory requirements. •Leads critical quality engineering and assurance tasks, ensuring the maintenance of manufacturing quality systems, ensuring risk management, and driving significant process improvement initiatives to facilitate New Product Introduction (NPI) completion and product transfers. Compensation: •$134,000 - $213,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!