Senior Capa Specialist Jobs

Work Flexibility: Onsite Stryker is hiring a Senior CAPA Specialist for the Joint Replacement division in Mahwah, NJ. Working within the QMS team to ensure compliance with CAPA processes and procedures and is responsible to but not limited to. Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests. What you will do · As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc. Support Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities by partnering with cross-functional teams to drive timely investigations and resolution of quality issues. Apply CAPA, root cause analysis, and problem-solving methodologies to support effective corrective and preventive actions. Maintain accurate and complete CAPA documentation within electronic quality management systems (e.g., TrackWise), ensuring required evidence and records are documented. Assist in facilitating CAPA review meetings and contribute to site, cross-functional, and global quality discussions. Monitor CAPA metrics and trends, prepare reports and provide data to support quality and business reviews. Provide guidance and support to CAPA process stakeholders, promoting consistent application of quality system requirements and procedures. Participate in training, process improvement, and continuous improvement initiatives to enhance CAPA effectiveness and compliance. Support internal, corporate

Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) Company: The Boeing Company Boeing Global Services (BGS) is looking for a Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) to join their Vertical Lift Quality Team in Mesa, AZ. This position will focus on supporting Vertical Lift Quality organization. Position Responsibilities: · Create and maintain the site Internal Audit Schedule · Maintain the site Internal Audit Program per AS9100 requirements · Promotes a healthy Quality Management System (QMS) rooted in process-based management methodologies · Performs process risk assessments · Writes Internal Audit reports and documents process non-conformance · Support process owners with corrective action process requirements · Performs and oversees Internal Audits – conduct assessments of processes and practices for comparison to applicable standards and requirements. · Maintain Internal Audit monthly metrics/KPIs · Provide monthly Internal Audit performance to the DQMR · Identified as the Process Owner for the Internal Audit Program that resides in the local Quality Management System · Align CAPA process with company and AS9100 requirements for Corrective Actions · Recommend and implement changes to the existing Internal Audit Program · Assist our business unit across Vertical Lift sites with continuous improvements and or lean projects · Use data for analysis trends and opportunities for improvement · Use experience and knowledge relative to all methods of Root Cause Corrective Actions, e.g., 5-Why, Fish bone, Boeing Problem Solving Model (BPSM)</

Work Flexibility: Hybrid What You Will Do / Roles & Responsibilities As a member of the Global Product Engineering team you will gain in depth knowledge about Stryker’s Trauma & Extremities portfolio. You will learn how Bone Plates & Screws, External Fixators, Surgical Instruments and many other products improve people’s life. Together we are responsible for over 50'000 articles. We count on you to maintain and improve our high standard in design specification and performance. You ensure compliance with applicable regulatory and quality requirements, including FDA, EU MDR, ISO 13485, and internal standards, by driving design change management activities, support regulatory submissions, and serving as a subject matter expert during internal and external audits. In your field of responsibility, you will make sure that design requirements are met as well as apply the design change process and identify technical solutions in this context. You oversee the continuous improvement projects for existing products in our group, create and manage project plans, assign and follow up on work packages. You participate in and at times lead cross functional teams to perform design related Non-Conformities(NC), Corrective- and Preventive-Actions(CAPA). Your role will include frequent contact with other teams such as the international Regulatory Affairs, Tech. Publications, Design Quality or Marketing to address design related questions for international registrations and creations of technical files required for the implementation of EU-MDR requirements. Drive value improvement, design optimization, and continuous improvement initiatives to enhance product performance, quality, compliance, and cost effectiveness. What You Need <

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock meetings

Job Title Site Leader (Director), Operations Quality Assurance- Job Description The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Pune (Chakan) manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives. Your Role: Lead all Operations Quality Assurance activities across the Pune (Chakan) manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance. Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites. As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity. Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements. Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness. Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA act

Job Details: Job Description: The Role and Impact As a Systems and Solutions Engineer, you will drive the design, development, and integration of systems that combine software, firmware, board, and silicon/SoC components to meet specific customer needs. In this role, you will play a key part in defining, implementing, and optimizing solutions to ensure high performance, reliability, and quality across the system lifecycle. Your work will directly impact the seamless functionality and user experience of cutting-edge technologies, enhancing Intel's position in delivering innovative systems to global customers. Business Group You will be joining the Silicon and Platform Engineering Group (SPE), an organization committed to advancing Intel's mission of delivering world-class silicon and platform solutions. The group focuses on developing integrated systems that align with customer needs and support Intel's broader goals of leadership in technology innovation. SPE collaborates across diverse domains to ensure Intel platforms meet performance, reliability, and scalability requirements. Key Responsibilities - Design and develop software, firmware, and hardware solutions that integrate seamlessly across system components. - Lead the definition and implementation of system architecture, translating business opportunities into technical requirements and use cases. - Evaluate technical risk and optimize systems for ease of use, reliability, security, availability, and sustainability. - Drive technical solutions to address customer challenges, deploying systems and conducting benchmarks to validate performance. - Collaborate with cross-functional teams to influence next-generation requirements and solutions, guiding research and academic collaborations as needed. - Conduct lab experiments to simulate real-life environments, analyze prototype performance, and refine system

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary: This is an individual contributor role. The Senior Manager negotiates, executes, conducts high level review and analysis, dispute resolution and/or settlement negotiations of contracts. Works with larger and more complex, market/regional/national based groups/systems in accordance with company standards to maintain and enhance provider networks while meeting and exceeding accessibility, quality and financial goals and cost initiatives. The Senior Manager will be responsible for contracting and implementing fee for service and value-based agreements with key physician groups, facilities, and ancillary providers to support commercial and individual exchange networks. This person will also work collaboratively with Aetna and CVS departments to identify initiatives to improve physician performance and quality of care provided to our members. Recruits providers as needed to ensure attainment of network expansion and adequacy targets. Accountable for cost arrangements within defined groups. Collaborates cross-functionally to manage provider compensation and pricing development activities, submission of contractual information, and the review and analysis of reports as part of negotiation and reimbursement modeling activities. What You’ll Do Lead end-to-end contract negotiations, execution, and analysis with a focus on hospital, ph

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary: As a Senior Software Development Engineer at Aetna, you will play a critical leadership role in the design, development, and continuous enhancement of enterprise-scale Provider Applications. You will drive technical solutions for complex business problems, ensure application stability, and lead cross-functional initiatives as a Project Owner. This role requires a balance of hands-on engineering expertise, technical leadership, and delivery ownership, including overseeing vendor/contractor teams, ensuring alignment with enterprise architecture, and delivering high-impact solutions that improve provider data systems and operational efficiency. Required Qualifications: 5&#43; years of hands-on application development experience with Python and Google Cloud Platform (GCP) 2&#43; years of experience leading or contributing to large-scale application development initiatives Preferred Qualifications: Experience working in Agile/SCRUM environments Proven experience in project/program management, including planning, execution tracking, and delivery management Strong organizational, leadership, and planning skills with the ability to manage multiple priorities Experience working with distributed teams and cross-functional stakeholders Prior exposure to

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. A Brief Overview As a Senior IT Project Manager, you will manage the resources, schedule and budget across teams, ensuring effective delivery. Your role focuses on creating an environment that enables team success, fostering collaboration, and driving continuous improvement. While this is a senior-level position, it is an Individual Contributor (IC) role, meaning you will influence and guide teams without direct people management responsibilities. What You Will Do Manage resources, schedule and budget. Design and develop tools and processes for effective team delivery. Analyze team productivity and quality data to generate actionable insights for improvement. Develop and execute stakeholder communication strategies to gather feedback and incorporate it into process enhancements. Implement knowledge-sharing systems (e.g., wikis, documentation platforms) to promote transparency and collaboration. Act as a liaison between teams and stakeholders, removing obstacles and ensuring smooth delivery. Minimum Requirements 7–10&#43; years of relevant experience in agile project management delivery or Scrum Master roles. Strong problem-solving and decision-making skills. Proven ability to collaborate effectively across teams and stakeholders.<

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. POSITION SUMMARY CVS Health is seeking a highly skilled Senior Data Engineer, Observability Engineering to join the Enterprise Observability Platform organization and help advance the next generation of observability, infrastructure, and security data capabilities. The Senior Data Engineer, Observability Engineering will play a critical role in designing, building, and operating scalable data pipelines and data products that power enterprise observability, operational intelligence, and security analytics across the organization. The Senior Data Engineer, Observability Engineering is a senior individual contributor responsible for developing and optimizing Databricks-based data engineering solutions that ingest, transform, govern, and deliver high-volume telemetry, infrastructure, application, and security data. This role combines deep hands-on technical execution with ownership of engineering excellence, operational reliability, performance optimization, and data platform best practices. Working closely with Observability Engineering, Security Engineering, Infrastructure Engineering, and Data Platform teams, the Senior Data Engineer, Observability Engineering will contribute to the evolution of the enterprise observability lakehouse by building resilient ingestion frameworks, establishing data quality standards, enhancing governance controls, and driving efficient, scalable data processing patter

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. A Brief Overview Remove impediments, foster cross-functional collaboration, support Product Owners, and meet with business leaders to support one or more major project initiatives for Medicare. This role differs from a traditional Scrum Master by having a broader focus on overall delivery flow and, often, a more direct hand in stakeholder management and project governance. Key Responsibilities Agile Coaching & Facilitation: Fostering a culture of continuous improvement, mentoring teams on Agile values, and facilitating ceremonies (stand-ups, planning, retrospectives). Delivery Management: Managing project scope, timelines, and dependencies while tracking progress through metrics like velocity and quality. Impediment Removal: Proactively identifying and clearing roadblocks that prevent the team from achieving goals. Stakeholder Alignment: Serving as a liaison between stakeholders and the team, managing expectations, and ensuring transparent communication. Process Improvement: Refining Agile practices to increase efficiency, quality, and effectiveness. Required Qualifications 7-10&#43; years of experience in Agile delivery, Scrum Master, Agile Coach, Program Delivery, or related roles. Familiarity with software development, DevOps, or technical

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary The Senior Manager, Project Management is responsible for leading and overseeing Coordination of Benefits projects and operational initiatives that improve payment accuracy, reduce overpayments, enhance compliance, and drive process efficiency across the organization. This role manages a portfolio of complex, cross-functional projects and collaborates with stakeholders across Claims, Enrollment, Provider Services, Operations, Technology, Analytics, and Vendor Management to ensure successful delivery of strategic business objectives. The Senior Manager is accountable for defining project scope, objectives, timelines, resource requirements, and success measures while ensuring initiatives are delivered on time, within budget, and aligned with organizational goals. This role leverages data analytics and business intelligence to identify trends, assess risks, develop solutions, and implement process improvements that enhance operational performance and the provider and member experience. In addition to project leadership, the Senior Manager directly manages staff, providing day-to-day leadership, coaching, performance management, and professional development. Responsibilities include establishing team priorities, allocating resources, managing workload distribution, fostering collaboration, and creating a culture of accountability, innovation, and continuous improvement. The role

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary The Senior Manager, Corporate Development — M&A Integration plays a critical role in advancing the organization’s mergers, acquisitions, divestitures, and strategic growth initiatives. This individual will support multiple transactions simultaneously and partner closely with business leaders and cross-functional teams to plan and execute due diligence, integrations, and separations. As a key member of the M&A Integration team, the Senior Manager will develop and manage value chain analyses, entanglement assessments, stranded-cost analyses, one-time cost evaluations, service grids, and transition services agreements for acquisitions and divestitures. The ideal candidate brings strong M&A execution experience, strategic thinking, financial acumen, stakeholder-management expertise, and the ability to deliver results in a complex, matrixed environment. Key Responsibilities Transaction Execution and Integration Support multiple acquisitions, divestitures, and strategic transactions concurrently. Partner with Corporate Development leadership to evaluate, plan, and execute complex transactions. Lead critical integration and separation planning activities to support smooth transitions and achieve transaction objectives. Develop and maintain transaction workplans, timelines, milestones, risk logs,

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary As an On-Site Wellness Coach, you will serve as a trusted health and well-being partner for employees at an assigned client location in Georgia. In this role, you will leverage your expertise in wellness coaching, behavior change, motivational interviewing, health education, and employee engagement to help individuals achieve sustainable lifestyle improvements and support organizational wellness goals. You will work directly with employees through one-on-one coaching, group programs, health screenings, and wellness initiatives designed to improve overall health outcomes, reduce health risks, and increase participation in employer-sponsored wellness programs. This role offers the opportunity to make a meaningful impact by helping employees build healthier habits related to nutrition, physical activity, stress management, sleep, weight management, and tobacco cessation. You will collaborate with employer leadership, wellness teams, and healthcare partners to deliver engaging wellness solutions that drive measurable results. You will accomplish this by: Providing individualized health and wellness coaching using evidence-based behavior change techniques and motivational interviewing. Conducting health risk assessments and reviewing biometric screening results to identify opportunities for health improvement. Creating customized wellness action pl