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Industrial Operations Team Lead

hace 2 semanas

Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**Job Overview**

 

This leadership role is responsible for overseeing the strategic direction of industrial operations, ensuring seamless production and delivery of high-quality medical devices. The ideal candidate will possess exceptional leadership skills, a strong technical background, and experience in managing cross-functional teams.

 

Key Responsibilities:

  • Lead engineering staff to prioritize projects, validate processes, and implement continuous improvements to maintain key performance indicators (KPIs) under control.
  • Collaborate with stakeholders to allocate resources effectively, meeting business needs and driving productivity.
  • Analyze data to prepare product and process reports, identifying trends and areas for improvement.
  • Familiarize yourself with financial structures and their impact on organizational results.
  • Develop cost estimates for validation activities and ensure they align with budgeted expectations.
  • Implement industry best practices for equipment and process qualification.
  • Maintain equipment operational readiness by coordinating calibration, maintenance, and repair services.
  • Analyze equipment performance data to ensure correct lifecycle management and inform future equipment selection decisions.
  • Evaluate potential risks related to product malfunctions and assess their financial, process, or quality impact.
  • Utilize statistical techniques to facilitate informed decision-making and draw conclusions from available data.
  • Ensure production lines meet product specifications and adhere to regulatory requirements.
  • Coordinate new ZFIN implementation activities and maintain current and compliant Master Production Plans (MPPs).
  • SUPPORT TRAINING PROCESS AND LEAD LOCAL CROSS-FUNCTIONAL TEAM ACTIVITIES.
  • Represent the manufacturing function on external cross-functional teams and participate in global initiatives.
  • Lead CAPA investigations and exception documents, as well as complex projects involving new product introductions, line expansions, and substantial product changes.
  • Identify and implement continuous improvement projects focusing on safety, quality, production, and cost optimization.

 

Qualifications:

  • Bachelor's degree in Engineering.
  • A minimum of 7+ years of manufacturing/process development experience.
  • Experience with statistical techniques, such as DOE and SPC.
  • Subject matter expertise in RCPS.
  • Knowledge of FDA, GMPs, and ISO regulations.
  • At least 2+ years of experience managing exempt technical personnel (Engineers).
  • Experience leading teams and validation plans for medical industry products and processes.
  • Project management experience involving coordination of cross-functional teams.
  • Fully Bilingual (English and Spanish).