Reasons could include the position has been filled orthe company is not accepting new applicants. Diversity - Innovation- Caring - Global Collaboration - Winning Spirit - High PerformanceAt our company, we value diversity and believe it is our greateststrength. We are committed to empowering women, supporting theLGBTQ+ community, and creating opportunities for individuals withdisabilities. Our belief is that your diversity enriches our workenvironment. As an equal opportunity employer, we wholeheartedlywelcome applications from all qualified candidates, regardless oftheir background. Additionally, we have a Gender Equality Policythat reflects our commitment to fairness and equality in theworkplace. Hybrid Roles: Boston Scientific's hybrid workplaceincludes Working From Home and onsite. You will have theopportunity to discuss details in the interview. About this roleBSC Cartago West is a greenfield Site requiring thecreation/implementation of a robust quality system in compliancewith applicable quality system regulations. This position will havethe unique opportunity to lead a cross-functional team to developprocedures that will lead to a successful launch of a PMA productthat contains MOAO and prepare the manufacturing site to hostsuccessful inspections by FDA and external Audits by NB.Responsible for supervising the implementation and maintenance ofall Quality Systems Elements, as described in the Corporate QualityManual, at BSC Costa Rica. Including special requirements relatedto Materials of Animal Origin. Also responsible for ensuring apermanent state of compliance with corporate and current applicableregulations. Responsible for driving a Culture of Compliance at BSCCosta Rica, for performing and facilitating Quality System relatedTraining, and driving the organization to be audit ready. Yourresponsibilities will 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 correct follow-up of action items related to thequality system to facilitate the closure of CAPAs and NCEPs, asrequired. - Drive BSC Costa Rica to build a proactive qualityCulture based on Substantial Compliance by providing relevanttraining, coaching, driving actions, and critical dissemination ofinformation. - Drive BSC Costa Rica to be in a state of constantreadiness to have successful audits by creating the procedures,driving behaviors, and capabilities required to host externalaudits. - Support QA Director during the activities of preparation,management, and hosting of External Audits. - Develop continuousimprovement initiatives of the Quality System by providingvisibility and defining activities where we can anticipate changesin the regulatory landscape. - Support the coordination andexecution of the Management Review meetings and assure the properdocumentation is kept, as per local/Corporate requirements. -Execute responsibilities and authorities related to ManagementReview meetings as per current procedures. Represent site on otherBoston Scientific Management Review forums, if required. -Supervise and assure a flawless execution of the Non-ConformingEvent and Prevention system (NCEP). - Act as Independent Reviewerfor significant projects or incidents that require this person’slevel of expertise. - May oversee the management of the InternalAudit Program by the Internal Quality Auditor. - May manage theFollowing Quality Areas: Labs of Calibrations and Microbiology,Documentation Center, Software Quality Engineering, QA-ProcessDevelopment Engineering Areas, Quality Release. - May perform asSite Head of Quality for eCAPA responsibilities (i.e., CAPATransfers). What we are looking for: - A successful candidate willhave strong project management skills. - Hold bachelor’s degree orabove in a technical/science career: Industrial, Electronic,Biotechnology, Electromechanical Engineering, or related field(Chemistry, Pharmacy, etc.). - 10 years of medical experience. -Experience Hosting Quality Audits/ FDA Inspections. - ASQCertification. - Knowledge of Six Sigma, Lean, APQP, or similartools. - Please submit Resume in English. Requisition ID: 602667 Asa leader in medical science for more than 40 years, we arecommitted to solving the challenges that matter most – united by adeep caring for human life. Our mission to advance science for lifeis about transforming lives through innovative medical solutionsthat improve patient lives, create value for our customers, andsupport our employees and the communities in which we operate. Nowmore than ever, we have a responsibility to apply those values toeverything we do – as a global business and as a global corporatecitizen. So, choosing a career with Boston Scientific (NYSE: BSX)isn’t just business, it’s personal. And if you’re a naturalproblem-solver with the imagination, determination, and spirit tomake a meaningful difference to people worldwide, we encourage youto apply and look forward to connecting with you! At BostonScientific, you will find a collaborative culture driven by apassion for innovation that keeps us connected on the mostessential level. With determination, imagination, and a deep caringfor human life, we’re solving some of the most important healthcareindustry challenges. Together, we’re one global team committed tomaking a difference in people’s lives around the world. This is aplace where you can find a career with meaningful purpose—improvinglives through your life’s work. #J-18808-Ljbffr