Senior Quality Operations Manager-Advanced Imaging

Philips Iberica SAU; Bedford (MA); On-site; USD 134,000 - 213,000; Full time

Benefits offered by this job

Generous PTO

401k with match

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Quality Operations Manager-Advanced Imaging to lead the Quality team and own strategic process validation, CAPA, NC/QN management, and design transfer activities in Bedford, MA. You will drive continuous improvements, ensure regulatory compliance, and collaborate across R&D, manufacturing, and regulatory affairs to uphold top-tier quality standards.

The role requires 10+ years in FDA-regulated medical devices, 3+ years leading teams, and a bachelor’s degree in

Qualifications

• 10+ years in FDA-regulated medical device quality operations/manufacturing environments.
• 3+ years leading quality teams including budgeting and workforce planning.
• Experience managing CAPA, non-conformances, root cause analysis and corrective actions.
• Knowledge of PFMEA, Change/Risk Management (ISO 14971) and regulatory guidelines.
• Ability to leverage quality data analytics across the product lifecycle.

Responsibilities

• Oversee strategic process validation initiatives and continuous improvements to product quality and manufacturing efficiency.
• Drive CAPA/NC/QN processes, ensure effectiveness and regulatory compliance.
• Lead PFMEA assessments related to design changes and manufacturing processes.
• Ensure robust validation of process controls and New Product Introductions (NPI) in factory settings.
• Collaborate with R&D, manufacturing and regulatory to raise supplier quality and reduce gaps.

Skills

Quality operations

CAPA management

Root cause analysis

Cross-functional collaboration

Regulatory compliance

Process validation

PFMEA

Education

Bachelor’s Degree in Quality/Engineering

ASQ-CQE or ISO Lead Auditor (desirable)

Job description

Job Title

Senior Quality Operations Manager-Advanced Imaging

Job Description

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.

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
• 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 NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
• May require travel up to 10%.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

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