**Job description:** Responsible for leading investigations into product deviations, ensuring that the root causes are identified, and appropriate corrective and preventive actions are taken. The role requires a deep understanding of regulatory requirements, quality systems, and root cause analysis techniques. The manager ensures that deviations are thoroughly documented, aligned with industry regulations, and resolved in a manner that minimizes risk to product quality and customer safety. Additionally, the role involves training staff, improving processes, and collaborating with multi-functional teams to develop a culture of continuous improvement in product quality management. **KEY RESPONSIBILITIES:** · Manage the deviation process from initiation to closure. Ensure that all deviations (i.e., discrepancies from standard operating procedures, specifications, or regulations) are gathered, investigated, and properly documented. · Coordinate and lead thorough investigations of product deviations, identifying root causes, and evaluating the impact of the deviations on product quality, safety, and regulatory compliance. · Work with teams across departments (e.g., Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to gather data, perform investigations, and identify potential process improvements. · Lead and guide the investigation team in conducting detailed root cause analysis to resolve underlying causes of product deviations. · Analyze the potential impact of deviations on product quality, customer safety, regulatory compliance, and business operations. This includes resolving if the deviation is isolated or if it affects multiple batches or products. · Based on investigation findings, be responsible for the development and implementation of corrective and preventive actions (CAPA) to address the root cause of the deviation and prevent recurrence. · Ensure that CAPA plans are appropriately designed, implemented, and evaluated for effectiveness. Verify that actions taken resolve the issue and lead to sustained improvements. · For critical deviations, ensure proper and timely reporting to regulatory bodies, following industry-specific regulations on how to handle quality deviations, adverse events, or product recalls. · Ensure all product deviations are thoroughly documented, including investigation findings, root cause analysis, corrective actions taken, and any follow-up activities. These records must be stored in accordance with regulatory and company policies! · Prepare detailed deviation investigation reports, summarizing the issue, investigation findings, corrective actions, and any preventive measures put in place. · Track deviation metrics, generate regular reports, and analyze trends to identify recurring issues or areas of risk that require attention! · If a deviation is related to raw materials or external suppliers, work closely with the supplier management team to address the issue and prevent future occurrences. **Required Skills:** · We are looking for a bachelor’s degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field. · Direct experience managing deviations and investigations in a manufacturing or production environment is highly valued. · Expertise in root cause analysis methodologies, including tools such as the 5 Whys, Fishbone diagrams, FMEA, and other quality improvement techniques. · Knowledge of Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices) · We are looking 5-10 years of Quality / relevant process experience in regulatory environment · Excellent communication skills to convey complex investigation results, corrective actions, and technical details to various collaborators, including management, regulatory bodies, and external auditors · We are looking 3-8 years of people leadership · Ability to lead and handle an onshore and offshore team · End to end process understanding. **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 more than 55,000 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 leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 360,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2022 global revenues of €22 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. Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law 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. **Job:** _Developer_ **Organization:** _ERD PPL US_ **Title:** _Senior CQR Engineer - Investigation/Deviation Manager_ **Location:** _VA-Richmond_ **Requisition ID:** _078234_