Manager I, Quality Systems Cartago

hace 4 semanas

Pereira, Risaralda, Colombia Boston Scientific A tiempo completo

Additional Locations: Costa Rica-Coyol Diversity - 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.
Your responsibilities 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 managed in the different quality systems including eCAPA.
Ensure correct follow-up of action items related to the quality system to facilitate the closure of CAPAs, Internal Audits, and Feeder System Investigations, as required.
Create and maintain a roadmap for compliance to Corporate/Site commitments to external bodies and drive effective implementation at BSC Costa Rica Site.
Drive BSC Costa Rica to build a proactive quality culture based on substantial compliance by providing relevant training, coaching, driving actions, and critical dissemination of information.
Ensure BSC Costa Rica is in a constant state of readiness for successful audits by creating the necessary procedures and capabilities required to host external audits.
Support QA Director during the preparation, management, and hosting of external audits.
Develop continuous improvement initiatives of the Quality System by providing visibility and defining activities to anticipate changes in the regulatory landscape.
Support the coordination and execution of Management Review meetings and ensure proper documentation is kept, as per local/Corporate requirements.
Execute responsibilities and authorities related to Management Review meetings as per current procedures.
May oversee the management of the Internal Audit Program by the Internal Quality 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 established requirements, if required.
Act as Independent Reviewer for significant projects or incidents that require this person's level of expertise.
May manage the Quality Labs of Calibrations and Microbiology.
May manage the Documentation Center.
May perform as Site Head of Quality for eCAPA responsibilities (i.e., CAPA Transfers).
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable: Assure that appropriate resources (personnel, tools, etc.)
are maintained to ensure Quality System compliance and adherence to the BSC Quality Policy.
Establish and promote 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 related field.
English Level desired: C1 (90-94%).
Experience managing 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 of experience in a similar position.
QS Integration knowledge and/or management is a plus.
QS and regulatory strategy for product transfer is a plus.
Please submit Resume in English.
Requisition ID: 595318 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.
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 Growth At 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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