Senior Medical Device Process Excellence Lead

Aventiqo; Batesville (IN); Presencial; USD 120.000 - 190.000; Jornada completa

Descripción de la vacante

Aventiqo is seeking a seasoned Process Improvement leader to drive end-to-end optimization of medical device operations. The role emphasizes Lean Six Sigma, regulatory compliance, and data-driven transformation across multiple functions.

The ideal candidate will hold a bachelor's degree in a related field, 15+ years in product development, quality systems or operational excellence, and advanced expertise in validated systems, AI governance, and change control within the medical products industry.

Formación

• Bachelor's degree in engineering, science, quality, operations, business, or related field.
• 15+ years of experience in product development, quality systems, operational excellence, process engineering, program management, or related discipline.
• Significant experience in the medical products industry
• Experience with validated systems, regulated digital tools, data governance, or AI governance
• Lean Six Sigma certification or equivalent demonstrated mastery

Conocimientos

Regulatory & Quality Knowledge

Deep knowledge of medical device

Design controls

Change control

Design history documentation

Quality system requirements

FDA QSR & ISO 13485 knowledge

Educación

Bachelor's degree in engineering/science/quality/operations/business

Advanced degree

Descripción del empleo

Aventiqo is seeking a seasoned Process Improvement leader to drive end-to-end optimization of medical device operations. The role emphasizes Lean Six Sigma, regulatory compliance, and data-driven transformation across multiple functions.

The ideal candidate will hold a bachelor's degree in a related field, 15+ years in product development, quality systems or operational excellence, and advanced expertise in validated systems, AI governance, and change control within the medical products industry.