Additional Locations: Costa Rica-Coyol Diversity -Innovation - Caring - Global Collaboration - Winning Spirit - HighPerformance At our company, we value diversity and believe it isour greatest strength. We are committed to empowering women,supporting the LGBTQ+ community, and creating opportunities forindividuals with disabilities. Our belief is that your diversityenriches our work environment. As an equal opportunity employer, wewholeheartedly welcome applications from all qualified candidates,regardless of their background. Additionally, we have a GenderEquality Policy that reflects our commitment to fairness andequality in the workplace. Hybrid Roles: Boston Scientific's hybridworkplace includes Working From Home and onsite. You will have theopportunity to discuss details in the interview. Yourresponsibilities include: - Supervise and assure a flawlessexecution of the corrective and preventive action system (CAPA). -Supervise the correct usage of investigation tools and techniquesin order to obtain effective corrective and preventive actions overthe issues managed in the different quality systems includingeCAPA. - Ensure the correct follow-up of action items related tothe quality system in order to facilitate the closure of CAPAs,Internal Audits, and Feeder System Investigations, as required. -Create and maintain a roadmap for compliance to corporate/sitecommitments to external bodies and drive effective implementationat BSC Costa Rica Site. - Drive BSC Costa Rica to build a proactivequality culture based on substantial compliance by providingrelevant training, coaching, and critical disseminating ofinformation. - Ensure BSC Costa Rica is in a state of constantreadiness to host successful audits by creating the procedures,driving behaviors, and capabilities required. - Support QA Directorduring the activities of preparation, management, and hosting ofexternal audits. - Develop continuous improvement initiatives ofthe Quality System by providing visibility and defining activitiesto anticipate changes in the regulatory landscape. - Support thecoordination and execution of the Management Review meetings andassure the proper documentation is kept, as per local/corporaterequirements. Execute responsibilities and authorities related to Management Review meetings as per current procedures. - May overseethe management of the Internal Audit Program by the InternalQuality Auditor. - Supervise and assure a flawless execution of the Non-Conforming Event and Prevention system (NCEP). - Act as Internal Quality Auditor or Lead Auditor, as per establishedrequirements, if required. - Act as Independent Reviewer forsignificant projects or incidents that require this person’s levelof expertise. - May manage the Quality Labs of Calibrations and Microbiology. - May manage the Documentation Center. - May performas Site Head of Quality for eCAPA responsibilities (i.e., CAPATransfers). In all actions, demonstrates a primary commitment topatient safety and product quality by maintaining compliance withthe Quality Policy and all other documented quality processes andprocedures. For those individuals that supervise others, thefollowing statements are applicable: Assures that appropriateresources (personnel, tools, etc.) are maintained to assure QualitySystem compliance and adherence to the BSC Quality Policy. -Establishes and promotes a work environment that supports the Quality Policy and Quality System. What we're looking for: -Bachelor's or Licenciature degree in Industrial Engineering or arelated field. - English Level desired: C1 (90-94%). - Experiencemanaging regulations for the medical device industry, i.e.,ISO13485 & QSR 820. - Process control knowledge is a must. -Experience managing people is a must. - At least 7 years ofexperience in a similar position. - QS Integration knowledge and/ormanagement is a plus. - QS and regulatory strategy for producttransfer is a plus. - Please submit your resume in English. Requisition ID: 595318 As a leader in medical science for more than40 years, we are committed to solving the challenges that mattermost – united by a deep caring for human life. Our mission toadvance science for life is about transforming lives throughinnovative medical solutions that improve patient lives, createvalue for our customers, and support our employees and thecommunities in which we operate. Now more than ever, we have aresponsibility to apply those values to everything we do – as aglobal business and as a global corporate citizen. So, choosing acareer with Boston Scientific (NYSE: BSX) isn’t just business; it’spersonal. If you’re a natural problem-solver with the imagination,determination, and spirit to make a meaningful difference to peopleworldwide, we encourage you to apply and look forward to connectingwith you! Benefits • Life-Work Integration • Community • CareerGrowth At Boston Scientific, you will find a collaborative culturedriven by a passion for innovation that keeps us connected on themost essential level. With determination, imagination, and a deepcaring for human life, we’re solving some of the most importanthealthcare industry challenges. Together, we’re one global teamcommitted to making a difference in people’s lives around theworld. This is a place where you can find a career with meaningfulpurpose—improving lives through your life’s work. #J-18808-Ljbffr IT