Job Information
Philips Senior Quality Manager-CAPA in Cambridge, Massachusetts
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:
CAPA Program/Team Leadership: Will own/manage the global CAPA process, ensuring timely identification, investigation, and resolution of quality issues. Oversees the root cause analysis process, applying best practices such as 5 Whys, Fishbone, FMEA, and other problem-solving methodologies. Ensures CAPA actions are effective, sustainable, and verified according to established quality system procedures. Develop and monitor key CAPA metrics (e.g., aging reports, effectiveness checks) to assess program performance and identify areas for improvement.
Global Quality Oversight: Provides strategic leadership and governance for CAPA activities across multiple regions, ensuring consistency and compliance with corporate quality standards. Will collaborate with the CAPA Center of Excellence and other Quality Managers to align CAPA processes and share best practices. Serves as the CAPA subject matter expert (SME) during internal and external audits, including FDA, ISO 13485, and other regulatory inspections.
Regulatory Compliance & Documentation: Ensures CAPA program adherence to global regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable regulations. Drives continuous improvement initiatives to enhance CAPA system robustness and documentation practices. Prepares and presents CAPA reports to senior leadership, providing insights on trends, risks, and mitigation strategies.
Cross-Functional Collaboration: Will partner with Service, Sales, Marketing, Engineering, Manufacturing, and Quality teams to address systemic issues and implement effective preventive actions. Drives design for quality initiatives by integrating CAPA learnings into product development and manufacturing processes. Leads and mentors 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 (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
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 (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Learn more about our culture. (https://www.careers.philips.com/na/en/our-culture-philips-careers)
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 (https://www.philipsusbenefits.com/) .
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%.
#LI-PH1
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran