Global Quality Director — Medical Devices

Integer Holdings Corporation; Tijuana; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Integer Holdings Corporation seeks a senior Quality leader to drive site quality across manufacturing operations. You will ensure regulatory compliance, elevate the local QMS within the Integer QMS, and lead initiatives to strengthen customer experience and product quality.

You’ll build a high-performing team, manage defects and CAPAs, and partner with engineering for robust design transfer. Required: 10+ years in regulated manufacturing with 6+ years in management, ASQ/ Six Sigma credentials,

Formación

• Bachelor's degree in quality engineering or related field; Master's preferred.
• ASQ Quality Manager/Engineer or Six Sigma Black Belt preferred.
• 10+ years of experience, including 6+ years in management in a Medical Device or other regulated manufacturing environment.
• Expertise in 21CFR820, ISO13485, ISO9001, EU MDR, GMPs, auditing, design controls and statistical concepts (DOE, Capability Studies, Validations).
• Strong problem-solving and communication; high emotional intelligence; limited travel (<25%).

Responsabilidades

• Provide energetic and strategic quality leadership to the manufacturing site(s) assigned.
• Ensure sites meet customer requirements while maintaining compliance with quality and regulatory standards.
• Elevate the local QMS within the Integer QMS and lead quality initiatives.
• Drive change management to design quality into product and process through robust characterization and capability activity.
• Serve as the management representative for the full local QMS and build a high-performing team.
• Liaise for customer quality escalations and review key quality records (CAPAs, NCRs, change notices).
• Develop talent through onboarding, development planning, and succession planning.

Conocimientos

Quality leadership

Regulatory compliance

Customer focus

Change management

Educación

Bachelor's degree in quality engineering or related field

Master's degree preferred

Herramientas

ASQ Quality Manager/Engineer

Six Sigma Black Belt

Descripción del empleo

Integer Holdings Corporation seeks a senior Quality leader to drive site quality across manufacturing operations. You will ensure regulatory compliance, elevate the local QMS within the Integer QMS, and lead initiatives to strengthen customer experience and product quality.

You’ll build a high-performing team, manage defects and CAPAs, and partner with engineering for robust design transfer. Required: 10+ years in regulated manufacturing with 6+ years in management, ASQ/ Six Sigma credentials,