Director, Quality and Regulatory CR

EDUCATION/ EDUCACIÓN:

• Bachelor’s degree in Engineering
• Desirable to have a Master’s degree in Administration, Project Management, etc.

EXPERIENCE/ EXPERIENCIA:

• More than 12 years of professional experience in a similar industry, in addition to a minimum of 10 years in upper-level positions Experience in the Medical Device industry, including ISO 13485 knowledge

SPECIALIZED KNOWLEDGE  / CONOCIMIENTO ESPECIALIZADO:

• Costa Rica local legislation knowledge
• EU MDR Regulations
• Medical Devices Single Audit Program (MDDAP)
• Design Control knowledge
• Regulatory Affairs knowledge
• Statistical knowledge

LANGUAGES REQUIRED FOR THE POSITION / IDIOMAS REQUERIDOS PARA EL PUESTO:

• Spanish/English 100% (written and oral)

COMPUTER TOOLS AND KNOWLEDGE LEVEL REQUIRED / HERRAMIENTAS INFORMÁTICAS Y NIVEL DE CONOCIMIENTO REQUERIDO:

• Microsoft Office: Intermediate                                                                                  
• Other tools: Visio, Project, Oracle & Agile 

QUALIFICATIONS / CUALIFICACIONES:

• Strategic Agility
• Standing Alone
• Managing Vision and Purpose
• Building Effective Teams
• Developing Direct Reports & Others
• Conflict Management
• Customer Focus
• Drive for Results
• Problem Solving
• Delegation

SUMMARY OF DUTIES AND RESPONSIBILITIES / RESUMEN DE FUNCIONES Y RESPONSABILIDADES:

Demonstrate strong leadership and provide strategic direction to the Quality and Regulatory Organization at the Costa Rica site. 

RESPONSIBILITIES RELATED TO TEAM FUNCTION

• Manage the activities, resourcing, and goals of each team to assure compliance and efficiency
  • Operational Excellence Quality team shall be able to support product lines through entire process – from receipt of components through manufacturing processes resulting in final product configuration; additionally process qualification developed by this team must assure consistent and reliable processes are developed, implemented and maintained. 
  • Quality and Regulatory team shall be able to maintain the QMS and associate programs (including but not limited to Doc Control, Product Release, CAPA, Audit, Training) to assure compliance with all applicable local and international regulations.  This team must support the planning for site expansion due to NPI, new technology, acquisitions, and transfers.  
  • Microbiology team shall ensure compliance of products and site to all applicable regulations related to the operation of clean rooms and manufacturing of sterile product. This team may also support the microbiology requirements of divisional sterile products produced by external manufacturers (contract manufacturers).
• Drive Quality initiatives to transform processes and environment to state of the art; initiatives will include assessments of progressive technology and applicability for use.
• Promote quality system improvements with a focus on value add, gain of efficiency, and implementation of poka-yoke mechanisms
• Responsible to meet department productivity and quality goals, supporting both Quality and Operation Key Performance Indicators (KPIs) while maintaining compliance to QMS and regulatory requirements.
• Responsible for regulatory compliance of site to all applicable regulations, including Medical Device Regulation (EU 2017/745), and for releasing product in accordance with these regulations.

RESPONSIBILITIES TO PEOPLE ON TEAM

• Manage the goals of each team to foster excellence and instill quality at the source while aligning with Quality and Site objectives
• Sponsor and guide team building and engagement using approaches such as: One on one meetings, open sessions, recognition based on results, positive confrontation, open door policy, effective listening, assertive communication, among others, to foster an adequate work environment
• Provide resource and personnel administration for team and individuals including but not limited to: recruiting, job description development, Individual Development Plans (IDP) activities.
• Oversee budget forecast, approval, monitoring of adherence, and assessment to adjust for all teams.
• Support and promote the implementation of EHS programs to ensure people safety and environment health.

RESPONSIBILITIES TO CROSS FUNCTIONAL CUSTOMERS

• Participate as a leader with Costa Rica site leadership to influence and impact overall approach to product quality, operational activities and employee environment. 
• Develop quality team leaders who create actively engaged quality team members who contribute to operational success while assuring compliance to processes and regulations.
• Support implementation of cost reduction projects
• Participate as site representative, as required, on Corporate Quality and Regulatory initiatives.
• Engage in companywide projects as required