Senior Quality Operations Manager-Advanced Imaging

Philips•Bedford, MA

9d•$134,000 - $213,000•Hybrid

About The Position

The Senior Quality Operations Manager is 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. This role involves managing talent within the Quality team, including selection, performance management, compensation, and career development. The manager will rigorously oversee the Corrective and Preventive Actions (CAPA) process, investigate nonconformances, determine root causes, implement corrective actions, and monitor their effectiveness. They will also manage Non-Conformances (NC) and Quality Notifications (QN). The role includes planning the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes, and assisting in Manufacturing Process Development and Design Transfer activities. Oversight of testing robustness for product transfer validations, reporting on project status for new products or transfers, and ensuring validation activities and employee capabilities to support process controls and New Product Introduction (NPI) or product transfers are also key responsibilities. The manager will drive initiatives to improve supplier quality, collaborating with R&D, manufacturing, and regulatory affairs. This position requires a deep understanding of products/services, leading cooperative efforts among project teams, and interacting with various stakeholders. The role also involves driving the resolution of quality non-conformities with internal suppliers and acting as the local factory-level QMS process owner for process validation. Critical quality engineering and assurance tasks, maintenance of manufacturing quality systems, risk management, and driving process improvement for NPI and product transfers are essential. The manager will analyze situations and data to resolve issues, implement strategic policies, and determine methods for achieving desired outcomes.

Requirements

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).
Minimum of 3+ years’ proven experience managing quality teams- budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
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.
Experienced in utilizing Quality, Reliability and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
Able to collaborate across R&D, manufacturing, and regulatory teams, build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
Experience in environmental control programs and sterilization validation.
Minimum of a Bachelor’s Degree in Quality, Engineering or similar disciplines or equivalent experience in Quality Engineering.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

ASQ-CQE, ISO Lead Auditor certifications-desired

Responsibilities

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.