Quality CAPA Specialist

About the job you’re considering

The CAPA Specialist is responsible for overseeing and supporting the development, implementation, and management of corrective and preventive action (CAPA) processes in compliance with FDA regulations, and other relevant industry guidelines. The individual will work cross-functionally with various departments to ensure that quality issues are investigated, root causes are identified, and effective corrective and preventive actions are implemented to ensure ongoing product quality and regulatory compliance.

Your role

• Manage the end-to-end CAPA process, including root cause analysis, corrective actions, and preventive measures.
• Ensure that all CAPA activities comply with FDA regulations, Good Manufacturing Practices (GMP), and relevant ISO standards, specifically related to medical devices (e.g., 21 CFR Part 820) and pharmaceuticals.
• Investigate non-conformities, deviations, and complaints to determine root causes.
• Work proactively with teams to identify potential risks and implement preventive actions to reduce the occurrence of non-conformances.
• Work with cross-functional teams to implement effective corrective actions.
• Analyze historical data, adverse events, and complaint trends to identify areas for improvement in the design, manufacturing, or post-market monitoring of medical products..
• Maintain accurate and up-to-date CAPA records and reports.
• Prepare and present CAPA metrics, trends, and effectiveness reports to senior management. Analyze trends in CAPA data to identify potential systemic issues that require attention.
• Conduct training on CAPA procedures and best practices.
• Support internal and external audits by providing CAPA records and evidence of compliance.

Your skills and experience

• Bachelor’s degree in Engineering, Quality, or Life Sciences related areas.
• 4-6 years of experience in CAPA management, quality assurance, or regulatory compliance.
• Strong knowledge of root cause analysis tools (e.g., 5-Whys, Fishbone Diagram, FMEA).
• Strong understanding of medical device regulations (21 CFR Part 820), pharmaceuticals (21 CFR Part 210/211), and ISO 13485.
• Familiarity with regulatory compliance tools, such as risk management software and CAPA management systems.

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini Engineering

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities &

Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.

Get the future you want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.