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 Assurance **Job Category:** Professional **All Job Posting Locations:** Grecia, Costa Rica **Job Description:** "Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 Orthopaedics** 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics 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 a Staff Quality Engineer to support our MedTech Orthopaedics business​ in Grecia, Costa Rica.** **Purpose:** The Senior Quality Engineer will provide support for installation, qualification and day-to-day sustaining activities for orthopedic implant and instrument manufacturing processes. They will utilize risk management and problem-solving skills to conduct effective technical reviews of the process and ensure quality, safety and efficacy of marketed devices. **You will be responsible for:** Under the direction of Quality Engineering and/or Quality Operations leadership, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: **New Product / Process Introduction** + Support new product introduction as part of design transfer. + Support planning and execution of manufacturing process qualifications including IQ, OQ, PQ, Process Verification and Test Method Validation (TMV) + Ensure that all critical to quality (CTQ) features are identified and adequately addressed in control plan by qualified test methods + Lead risk management activities and develop process FMEAs to ensure that process risk has been fully assessed, appropriate risk controls implemented, and risk reduced as far as possible **Product Quality, Control & Disposition and Performance Standards** + Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. + Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. + Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. **Business Improvements** + Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. + Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. + Conduct benchmarking to develop more effective methods for improving quality. + Drive Continuous Improvement and Risk-Reduction Projects: Identify and implement improvement initiatives using Lean Six Sigma, PFMEA, and SPC methodologies to enhance process capability and product reliability. Lead projects focused on yield improvement, scrap reduction, and cost optimization while maintaining regulatory compliance. + Lead or Support High-Visibility and Strategic Projects: Serve as Quality representative in cross-functional or global initiatives such as line transfers, NPIs, and critical equipment validations. Communicate progress, risks, and results to senior leadership, ensuring visibility and alignment with corporate priorities. **Compliance / Regulatory** + Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. + Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. + Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate. Ensure Robustness and Compliance of the Quality Management System (QMS): Oversee the effective implementation of key QMS elements such as CAPA, Change Control, Supplier Quality, and Process Validation. Review and approve technical documentation (protocols, reports, specifications, and work instructions) to ensure regulatory consistency. Participate in internal and external audits, leading corrective and preventive actions to sustain compliance. + Promote Operational Excellence and a “Right First Time” Culture: Promote quality culture aligned with FDA, ISO 13485, and MDSAP standards. Be a strong presence on the manufacturing floor (Gemba), leveraging visual metrics and trend analysis to identify and prevent issues early. Foster accountability, recognition, and teamwork as foundations of a high-performance quality culture. **Other:** + 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. + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Performs other duties assigned as needed. + Lead Technical and Professional Development of the Quality Team: Mentor engineers and technicians to strengthen their capabilities in root cause analysis, validation, regulatory documentation, and data-driven decision-making. **Qualifications / Requirements:** EXPERIENCE AND EDUCATION + A minimum of a University bachelor’s degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science. + 2-4 years experience as a Quality Professional in the Medical Device Industry required. + Demonstrated knowledge of manufacturing principles and practices, and procedures. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES + **Required:** + Excellent communication skills in English, spoken and written. + Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably. Capacity to solve problems providing good judgment is highly desired. + Experience conducting Process Verification / Validation + Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis + Interpersonal skills that foster collaboration as it relates to technical situations + Strong initiative and follow-through in completing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or leadership experience + **Preferred:** + Experience with inspection & test methods including GD&T + Experience working with ERP systems and associated Quality process flows + Strong experience with Six Sigma or Lean + Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus **Required Skills:** **Preferred Skills:** Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards