At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Systems **Job Category:** People Leader **All Job Posting Locations:** Grecia, Costa Rica **Job Description:** "Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.” **About Orthopedics** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **We are searching for the best talent for Senior Quality Systems Manager to support our MedTech Orthopedics business​ in Grecia, Costa Rica.** **Purpose:** The Quality Shared Services Manager spearheads the planning, implementation, execution, standardization, and management of a robust Quality System. This role encompasses critical areas such as Corrective and Preventive Actions (CAPA), Nonconformance, Training, Change Control and the deployment of Digital Business Systems to enhance and maintain the Quality Management System. **You will be responsible for:** In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Develop, implement, and maintain comprehensive policies and procedures to ensure full compliance with local, state, and federal regulations applicable to the manufacturing of medical devices. + Manage and oversee CAPA, Nonconformance, Training, Change Control. + Monitor Quality System performance consistently, identifying and escalating any issues or trends in Quality System review forums such as Management Review and Data Review Boards. + Coordinate and prepare materials for Data Review Boards and Management Reviews, compiling information from various sites, managing the review process, recording minutes, tracking action items, and maintaining thorough documentation. + Lead the deployment of new MedTech Quality Digital Systems and enhancements to existing systems to optimize efficiency and compliance by: + Leading systems deployment in alignment with the Capital Appropriation Requests and manage the Scope, schedule, quality & budget of the deployments. + Working with the Business Lead & IT lead, form the key leadership responsible for the successful deployment. + Support the Stage Gate deployment operating model for specific deployments. + Ensure effective and timely communications with respect to system deployment both within J&J MedTech Costa Rica and with key partners + Stay current with FDA and EU regulations and global quality standards specific to the medical device industry, proactively implementing changes as necessary. + Champion adherence to Health, Safety, and Environmental practices, ensuring all team members have access to required resources. + Accountable for Records Retention activities including but not limited to: + Responsible for ensuring review and management of records retention schedules for Corporate, including annual departmental reviews and public updates throughout the year, as required. + Ensures the execution of annual records reviews, periodic records management training and department records coordinator meetings. + Leads the formulation of long-term plans for the owner's information systems for records retention and information security that support strategic objectives, as well as the implementation and ongoing support of the same. + Accountable for Training Management activities including but not limited to: + Establishes and maintains a solid Training Program to ensure the compliance with all the local, national and international regulatory standards, as well as with the processes and policies of the company and the requirements of the J&J corporation. + Integrates the Training teams of the Johnson and Johnson MedTech Costa Rica Campus and J&J Business units to coordinate the implementation of Training plans. + Responsible for communicating business-related issues or opportunities to next management level + Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. + For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. + Perform additional duties as assigned to support departmental and organizational goals. **Qualifications / Requirements:** EXPERIENCE AND EDUCATION + University bachelor’s degree in chemistry, Biology, Engineering, or a related field. Master’s degree preferred. + Minimum of 8-10 years of experience in an FDA-regulated industry, with experience in a managerial role, preferable related to Quality Systems within the Medical Device sector. + Bilingual English Spanish + Experience of delivering Quality System’s deployments. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES + Functional knowledge of/and experience in systems within Medical Device. + Knowledge of GXPs and Sox requirements and regulations. + Previous experience in working within a support organization with a knowledge of functional and matrix structures. + Strong and proven project management experience + Strong communication skills and change management + Managing risk, including escalation, prioritization and resolution of systems and support issues and developing and managing responses + Building consensus and impacting outcome with authority and ability to negotiate trade off decisions across the organization + Must have strong collaboration and influencing skills to partner effectively at all levels and across multiple groups. + Strong capability to leverage regulatory, technical, and business knowledge for leading and managing quality system improvement projects. + Evident root cause analysis and problem-solving abilities. + Strong communication skills, enabling effective interaction with internal and external stakeholders. + Solid business and financial acumen. \#LI-Onsite **Required Skills:** **Preferred Skills:** Collaborating, Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Data Quality, Developing Others, Incident Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Team Management