Senior Quality Operations Manager-Advanced Imaging

Job Title

Job Description

The Senior Quality Operations Manager is responsible for managing the Quality Operations team, site leadership, overseeing strategic process validation initiatives, driving targeted/continuous improvements to optimize product quality /manufacturing efficiency, managing CAPA/MRB/Nonconformance processes and ensuring compliance with regulatory standards and operational excellence.

Your role:

• Manages talent across the Quality team (5-7 Quality Operations Engineers/QC Inspectors), 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), MRB 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 manufacturing environments, with a focus on site leadership, quality operations, audit/audit readiness, process validation/improvement, CAPA, non-conformance, MRB, 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 strong experience in Quality transformation, change management, and driving a culture of quality excellence.
• You have extensive experience in FDA/Notified Body audits, including audit readiness, remediation activities, and front-room audit experience.
• 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 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-desired.
• You have a minimum of a Bachelor’s Degree in Engineering (Required). ASQ-CQE, ISO Lead Auditor certifications-desired
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office Based role

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• 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 multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

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.
• Company relocation benefits WILL NOTbe provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
• May require travel up to 10%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.