Senior Site Quality Leader - Medical Devices & Compliance

Abbott; Plymouth (MN); On-site; USD 149,000 - 299,000; Full time

Benefits offered by this job

HIP PPO health coverage

Retirement savings plan with employer®

Tuition reimbursement and FreeU

Job summary

Abbott is seeking a Site Quality Leader in Plymouth, MN to serve as the senior quality authority for the site and a core member of the Site Leadership Team. You will ensure all products meet global regulatory requirements and conform to the Abbott Structural Heart Quality System.

You will establish and lead the quality strategy, drive regulatory compliance, and maintain the Quality Management System for finished Structural Heart devices and components manufactured in Minnesota facilities.

Qualifications

• Bachelor's or advanced degree in Engineering or related field.
• Minimum 12 years of Medical Device manufacturing experience including significant quality leadership roles.
• Comprehensive understanding of FDA, EU MDR, and global regulatory requirements.
• Proven experience leading and developing quality teams in a medical device manufacturing environment.
• Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control.
• Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across all organizational levels.

Responsibilities

• Establish and implement a site quality strategy aligned with business objectives and regulatory expectations.
• Represent Quality on the Site Leadership Team and embed quality principles into site decision making.
• Promote a proactive quality culture focused on risk management, compliance, and continuous improvement.
• Ensure full compliance with global regulatory standards including EU MDR, FDA QMSR, ISO 13845.
• Maintain continuous inspection readiness and lead regulatory inspections.
• Provide quality oversight for Structural Heart manufacturing processes.
• Lead and develop the site quality organization.

Skills

Engineering degree

Quality leadership

Regulatory collaboration

Written and verbal communication

Education

Bachelor's degree in Engineering or related field

Tools

CAPA system

Change control

Deviation management

Document control

Job description

Abbott is seeking a Site Quality Leader in Plymouth, MN to serve as the senior quality authority for the site and a core member of the Site Leadership Team. You will ensure all products meet global regulatory requirements and conform to the Abbott Structural Heart Quality System.

You will establish and lead the quality strategy, drive regulatory compliance, and maintain the Quality Management System for finished Structural Heart devices and components manufactured in Minnesota facilities.