Senior Quality Operations Manager-Advanced Imaging

About the role

We are seeking a Senior Quality Operations Manager to oversee strategic process validation initiatives, drive continuous improvements to optimize product quality and manufacturing efficiency, manage CAPA/Nonconformance processes, and ensure compliance with regulatory standards and operational excellence.

Responsibilities

• Manage talent across the Quality team, including employee selection, performance management, compensation, career development, and operational management.
• Rigorously manage the Corrective and Preventive Actions (CAPA) process, investigating nonconformances, determining root causes, and implementing robust corrective and preventive actions while monitoring CAPA effectiveness.
• Oversee the management of Non-Conformances (NC) and Quality Notifications (QN).
• Assess the impact on Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes.
• Assist in Manufacturing Process Development and Design Transfer activities.
• Provide oversight for testing the robustness of product transfer validations in the factory.
• Report on project status of new products or transfers to the factory.
• Ensure validation activities and employee capabilities support the validation of process controls and completeness of New Product Introduction (NPI) or product transfers into the factory to quality norms.
• Drive strategic initiatives to elevate supplier quality standards, collaborating with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and uphold superior quality benchmarks.
• Lead cooperative efforts among project team members, interacting with subordinates, supervisors, customers, and functional peer groups on matters between functional areas.
• Drive resolution of quality non-conformities with Philips internal suppliers.
• Act as the local factory-level QMS process owner for process validation to ensure adherence to quality standards and regulatory requirements.
• Lead critical quality engineering and assurance tasks, maintaining manufacturing quality systems, ensuring risk management, and driving significant process improvement initiatives to facilitate NPI completion and product transfers.
• Analyze situations or data requiring an in-depth understanding of organizational objectives and implement strategic policies to determine methods, techniques, and evaluation criteria for 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, including budgeting, workforce planning, performance management, employee engagement/retention, succession planning, coaching, and training.
• Detailed experience/knowledge in managing CAPA processes and non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence, and driving continuous improvement.
• Experience utilizing Quality, Reliability, and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• Ability to collaborate across R&D, manufacturing, and regulatory teams, and build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, and suppliers.
• 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.
• ASQ-CQE and ISO Lead Auditor certifications are desired.
• Ability to successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.

Schedule

This is an office-based role requiring full-time (5 days per week) presence in the company’s facilities, with at least 3 days per week in-person. May require travel up to 10%.

Pay

The pay range for this position in Bedford, MA is $134,000 to $213,000. The actual base pay offered may vary within the posted ranges depending on job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Additional compensation may include an annual incentive bonus, sales commission, or long-term incentives.

Benefits

• Comprehensive Philips Total Rewards benefits program, including generous PTO.
• 401k with up to 7% match.
• HSA with company contribution.
• Stock purchase plan.
• Education reimbursement.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. For this position, you must reside in or within commuting distance to Bedford, MA. Company relocation benefits will not be provided.