Senior CAPA Manager

Job TitleSenior CAPA ManagerJob DescriptionThe Senior CAPA (Corrective and Preventative Actions) Manager is a key member of the Sleep & Respiratory Care (S&RC) Patient Safety and Quality organization, responsible for managing/leading a high performing team responsible for driving CAPA activities from issue identification to closure.Your role:You will Manage, lead and mentor cross functional teams of CAPA Facilitators with the implementation of appropriate root cause analysis techniques, Project manage all aspects of CAPA activity, which includes gaining the commitment of cross functional resources, scheduling team meetings, ensuring deliverables per project timelines, ensure the quality of CAPA record content and represent CAPA’s during audits and CAPA Review Board meetings.You will facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.You will analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.You will work with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.You're the right fit if:You have a minimum of 8 years’ experience focused on Corrective and Preventative Actions (CAPA) in FDA regulated medical device/product environments, with a minimum of 3 years’ functional management experience, developing and mentoring high performing quality teams.You’re able to understand and analyze complex problems, including software and hardware design issues and have demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.You have a strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.You’ve demonstrated strong CAPA Project Management skills, including the ability to analyze data/apply statistical techniques and ability to partner with the business and effectively interact with/ influence employees, and managers on all levels.You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines, Master’s Degree desired. ASQ certifications-Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or DfSS Green Belt/Black Belt preferred.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 apart. 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 commitment to diversity and inclusion.Philips Transparency Details:The pay range for this position in Cambridge, MA is $116,000 to $200,000.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.    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. 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. Additional InformationUS 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 Cambridge, MA.#LI-PH1This 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.Job SummaryJob number: 539355Date posted : 2024-11-18Profession: Quality & RegulatoryEmployment type: Full time