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:** Business Enablement/Support **All Job Posting Locations:** Grecia, Costa Rica **Job Description:** · Applies functional knowledge of Quality Assurance requirements to execute organizational objectives. · Helps track review of documentation associated with processes and activities related to the organization's products. · Supports routine data collection, analysis, and reporting to ensure the continuous improvement of the quality management system. · Follow formal escalation processes to ensure visibility of risks associated with product quality, regulatory compliance, and quality systems. · Maintains quality policies and procedures and makes updates based on new or revised regulatory requirements, internal investigations, and audits. · Assists other administrative team members in executing tasks that are both routine and complex. · Initiate non-conformances for product outside specification, including all required containment actions to prevent unintended use. Actively participate in the product investigation of non-conformances to address and support the identification of test method related root causes · Collaborates to investigate and to documents corrective actions or corrections (for audit observations, NR, etc) assigned, ensuring timely approval and closure. · 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 · Perform basic Preventive Maintenance routines such as cleaning equipment among others. · Identify and report misalignments between applicable procedures. · Identify and document opportunities for improvement applicable to the work area · 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 a 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. · Performs other duties assigned as needed. **Required Skills:** **Preferred Skills:** Accountability, Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing