Work mode: Hybrid

Onsite Location(s):Cartago, A, CR

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 manage in the different quality systems including e CAPA.
• Be sure of having the correct follow up of action items related to the 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/Site Commitments to External bodies and driving for 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 disseminating of information to ensure.
• 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.
• 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 e CAPA responsibilities (i.e CAPA Transfers )

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System 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:

• Bachelors or Licenciature degree in Industrial Engineer or Field Related.
• English Level desired: C1:(90-94%).
• experience on managing regulations for medical device industry, ie ISO13485 & QSR 820
• Process control knowledge is a must.
• Experience managing people is a must.
• At least 7 years of experience in 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