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:** Professional **All Job Posting Locations:** Alajuela, Costa Rica **Job Description:** Johnson & Johnson is hiring for a **Quality Systems Engineer I** to join our team located in **Shockwave Medical Costa Rica.** **Position Overview** In compliance with FDA, European MDD/MDR & & other International Regulations, the Quality Systems Engineer I will perform work under supervision. General scope of this position is to support the NCR process, Data analysis, internal and external audits and monitoring of the of key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards. **Essential Job Functions** + Assist with audit activities. + Participate in quality system activities and support internal and external audits. + Assist in the coordination of audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channel etc.) + Interface with Subject Matter Experts regarding the audit requests. + Assist with managing the NCR System + Work cross-functionally with other teams to track and manage NCR activities from initiation through closure + Assist with affected product identification, segregation, investigation and final disposition + Identify and implement QMS system continuous improvement activities + Maintain records per procedure requirements + Compile quality metrics for trending purposes + Compile data and prepare presentations as needed. + Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities. + Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. **Requirements** + Bachelor’s degree in related Engineering (Industrial, Quality, others) + English Proficiency. + Experience in the medical device industry is desired. + Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus. + Ability to compile and analyze data, present information, and demonstrate competent document writing skills. + Excellent written and verbal communication skills. + Basic knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems. ISO 14001 knowledge is a plus. + The ability to understand and follow QMS Procedures. (e.g., SOP and Test Methods.) + Experience with computer-based applications (MS Word, MS Excel, Power Point). + Strong time management skills and the ability to multi-task in a fast-paced environment. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. **Required Skills:** **Preferred Skills:**