Design Quality Leader — Assurance & Systems

Integer Holdings Corporation; Florida; On-site; USD 110,000 - 150,000; Full time

Job summary

Integer Holdings Corporation in Florida is seeking a Design Center Quality Leader to oversee Quality Systems and Design Assurance. You will manage a team, set priorities, and drive the quality strategy to meet site and customer expectations.

The role requires leading cross-functional collaboration with R&D and Operations, ensuring robust design controls, risk management, and effective transfer of new products to production. Experience with FDA and ISO requirements is essential.

Qualifications

• Bachelor's degree in engineering or related field required.
• Minimum 5 years of experience in quality, design assurance or design & development.
• Proficient in problem solving and quality system concepts (FDA/ISO).

Responsibilities

• Lead and manage the Design Center Quality Team (Quality Systems and Design Assurance).
• Develop and monitor metrics to drive quality objectives and improvements.
• Ensure compliance with FDA QSR, ISO 13485, and related regulations.
• Oversee design transfer activities and collaborate with R&D and Operations.
• Manage CAPA, document control, internal audits, and trainings.

Skills

MiniTab

Office Suite

Problem solving

Education

Bachelor's degree in engineering or related field

5 years minimum of related experience in quality, design assurance and/or design & development

Job description

Integer Holdings Corporation in Florida is seeking a Design Center Quality Leader to oversee Quality Systems and Design Assurance. You will manage a team, set priorities, and drive the quality strategy to meet site and customer expectations.

The role requires leading cross-functional collaboration with R&D and Operations, ensuring robust design controls, risk management, and effective transfer of new products to production. Experience with FDA and ISO requirements is essential.