NPI QE Team Lead
- Costa Rica
- Permanente
- Tiempo completo
- Work and lead cross-functional teams using the Product Development Process to ensure robust systems.
- Ensure the production of defect-free products, meeting business goals and customer expectations.
- Participate in and lead Transfer Projects, covering all related activities (Qualification Process, Test Method Validation, Inspection Methods, Validation Master Plan, FMEA, Quality Plans, among others).
- Work in unique and/or adverse situations, gather and review information from various functional areas, and make appropriate, fact-based quality recommendations.
- Proficient in Geometric Dimensioning and Tolerancing (GD&T) and blueprint reading.
- Ability to conduct and interpret Gage R&R studies.
- Hands-on experience in metrology using a wide range of metrology tools.
- Skilled in teaching and implementing new concepts in manufacturing, engineering, and inspection.
- Ability to implement effective sampling plans.
- Strong problem-solving, project management, and communication skills.
- Experience implementing inspection sampling plans.
- Contribute to Continuous Improvement projects as needed.
- Support maintenance activities for qualified processes.
- Support Quality System activities as needed (training, CAPA, documentation, suppliers, among others).
- Bachelor's degree in engineering or in a science/technical/business-related field (or equivalent to 4 years of experience in a related field).
- Experience and/or training related to knowledge of 21 CFR 820 (Quality System Regulation/Good Manufacturing Practices for medical devices), and ISO 13485 and ISO 14971 standards.
- Internal Auditor training (Preferred).
- Advanced English.
- At least 3-5 years of experience managing people.