Job Title

Job Description

The Senior Quality Manager-CAPA will play a critical role within Philips’ Global Patient Safety & Quality organization by leading and managing the Corrective and Preventive Action (CAPA) Program/Team for our global operations.

Your role:

• Will be responsible for Product Hold Management & Transparency, including identification of all products and materials currently on hold, ensuring clear visibility across teams. Establishing a defined timeline and necessary actions to release products/materials from hold. Maintaining a centralized tracking system for holds and ensure alignment with business priorities.
• Responsible for Global Quality Oversight, including strategic leadership and governance for CAPA activities across multiple regions, ensuring consistency and compliance with corporate quality standards. Collaborating with the CAPA Center of Excellence and other Quality Managers to align CAPA processes and share best practices. Serving as the CAPA subject matter expert (SME) during internal and external audits, including FDA, ISO 13485, and other regulatory inspections.
• Responsible for Regulatory Compliance & Documentation, ensuring CAPA program adherence to global regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable regulations. Driving continuous improvement initiatives to enhance CAPA system robustness and documentation practices. Preparing/presenting CAPA reports to senior leadership, providing insights on trends, risks, and mitigation strategies.
• Will have a focus on cross-functional collaboration, partnering with Service, Sales, Marketing, Engineering, Manufacturing, and Quality teams to address systemic issues and implement effective preventive actions. Driving design for quality initiatives by integrating CAPA learnings into product development and manufacturing processes. Leading and mentoring a team of quality professionals, providing guidance on CAPA investigations and documentation.

You're the right fit if:

• You have a minimum of 10+ years’ experience in Quality Assurance/Engineering, within FDA regulated medical device environments, with proven functional leadership experience and expertise in CAPA program management, root cause analysis, corrective actions, End to End QMS, Post Market Surveillance, Design Control and verification of effectiveness.
• You have In-depth knowledge of global medical device regulations (FDA, ISO 13485, MDR), industry standards and experience in managing/presenting during regulatory audits.
• You have strong analytical/problem-solving skills, with proficiency in quality tools and statistical analysis.
• You have excellent leadership, communication, and cross-functional collaboration abilities.
• You’re experienced with electronic quality management systems (QMS).
• You have strong project management skills (MS Project preferred) with the ability to lead multiple initiatives simultaneously.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering (Mechanical, Biomedical, Electrical) or a related technical discipline. Certified Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) 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 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 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 Nashville, TN is $114,000 to $183,000.
• The pay range for this position in Cambridge, MA is $128,000 to $205,000.

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 Nashville, TN or Cambridge, 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/Disabled/Veteran and maintains a drug-free workplace.