Quality Systems, Sr Manager Cartago

hace 2 semanas

Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

Additional Locations: Costa Rica-CoyolDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At our company, we value diversity and believe it is our greatest strength.
We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities.
Our belief is that your diversity enriches our work environment.
As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background.
Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.
Hybrid Roles:Boston Scientific's hybrid workplace includes Working From Home and onsite.
You will have the opportunity to discuss details in the interview.
About this roleBSC Cartago West is a greenfield Site requiring the creation/implementation of a robust quality system in compliance with applicable quality system regulations, this position will have the unique opportunity to lead a cross functional team to develop procedures that will lead to a successful launch of a PMA product that contains MOAO and prepare the manufacturing site to host successful inspections by FDA and external Audits by NB.
Responsible for supervising the implementation and maintenance of all Quality Systems Elements, as described in the Corporate Quality Manual, at BSC Costa Rica.
Including special requirements related Materials of Animal Origen.
Also responsible for ensuring a permanent state of compliance with corporate and current applicable regulations.
Responsible for driving a Culture of Compliance at BSC Costa Rica,  for performing and facilitating Quality System related Training, driving the organization to be audit ready.Your responsibilities will include:Supervise and assure a flawless execution of the corrective and preventive action system (CAPA).Supervise the correct usage of investigation tools and techniques in order to obtain effective corrective and preventive actions over the issues manage in the different quality systems including eCAPA.Be sure of having the correct follow up of action items related to the quality system in order to facilitate the closure of CAPAs and NCEPs, as required.Drive BSC Costa Rica to build a proactive quality Culture based on Substantial Compliance by providing relevant training, coaching, driving actions and critical disseminating of information.Drive BSC Costa Rica to be in a state of constant readiness to have successful audits by creating the procedures, driving behaviors and capabilities required to host external audits.Support QA Director during the activities of preparation, management and hosting of External Audits.Develop continuous improvements initiatives of the Quality System by providing visibility and defining activities where we can anticipate changes in the regulatory landscape.Support the coordination and execution of the Management Review meetings and assure the proper documentation is kept, as per local/Corporate requirements.
Execute responsibilities and authorities related to Management Review meetings as per current procedures.
Represent site on other Boston Scientific Management Review forums, if required.Supervise and assure a flawless execution of the Non Conforming Event and Prevention system  (NCEP).Act as Independent Reviewer for significant projects or incidents that require this person´s level of expertise.May oversee the management of the Internal Audit Program by the Internal Quality Auditor.May manage the Following Quality Areas:Labs of Calibrations and Microbiology, Documentation Center, Software Quality Engineering, QA-Process Development Engineering Areas, Quality Release.May perform as Site Head of Quality for eCAPA responsibilities  (i.e CAPA Transfers).What we are looking for:A successful candidate will have strong project management skillsHold bachelor's degree or above 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 Inspections90% EnglishMaster Degree desirableASQ CertificationKnowledge of Six Sigma, Lean, APQP or similar toolsPlease submit Resume in English  Requisition ID: 602667 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
Benefits
• Life-Work Integration
• Community
• Career GrowthAt Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges.
Together, we're one global team committed to making a difference in people's lives around the world.
This is a place where you can find a career with meaningful purpose—improving lives through your life's work.

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