Hiring: Senior Quality Manager-Advanced Imaging Company: Philips Location: Bedford, MA Job Posted Time: 2026-09-03 10:28:41 Employment Type: Full-time Target Skills & Keywords : R, Regulatory Compliance About the job Experience: •8+ years’ experience in FDA regulated medical device environments, with a focus on Quality Management System (QMS) Compliance, and Design Assurance functions. Required Skills: •The Senior Quality Manager-Advanced Imaging provides leadership for the Quality Management System (QMS) and Design Assurance functions, ensuring the delivery of safe, effective, and compliant Image Guided Therapy products throughout the product lifecycle. •Lead the Quality functions as a strategic member of the leadership team, fostering a culture of quality, compliance, and continuous improvement across the organization. •Provide oversight of the Quality Management System (QMS), ensuring compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), and other regulatory requirements. •Serve as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies. •Establish, maintain, and continuously improve quality processes, systems, and procedures to ensure the delivery of safe, effective, and high-quality products. •Lead and develop a high-performing quality organization through effective talent acquisition, performance management, coaching, succession planning, and employee development. •Monitor and analyze quality system and product performance metrics, driving data-based decision making and strategic improvement initiatives. •Partner cross-functionally with R&D, Operations, Regulatory Affairs, and other functions to resolve quality issues, support business objectives, and ensure effective execution of quality strategies. 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!