Senior Quality Operations Manager-Advanced Imaging

Your role:

• 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.
• Provides oversight for testing robustness of product transfer validations in the factory, report on project status of new products or transfers to factory and ensures validation activities and employee capabilities to support validation of process controls and completeness of New Product Introduction (NPI) or product transfers into factory to quality norms.
• 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.
• Manages issues necessitating an in-depth understanding of organizational objectives through the analysis of situations or data and implements strategic policies when determining methods, techniques, and evaluation criteria to achieve desired outcomes.

You're the right fit if:

• You have a minimum of 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).
• You have a minimum of 3+ years’ proven experience managing quality teams- budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have detailed experience/knowledge in managing CAPA processes, non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in utilizing Quality, Reliability and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• You’re able to collaborate across R&D, manufacturing, and regulatory teams, build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
• You have experience in environmental control programs and sterilization validation.
• You have a minimum of a Bachelor’s Degree in Quality, Engineering or similar disciplines or equivalent experience in Quality Engineering.
• ASQ-CQE, ISO Lead Auditor certifications-desired