Senior Quality Leader, Structural Heart Devices

Abbott; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Free medical coverage

Tuition reimbursement

Strong retirement savings plan

Education benefit

Job summary

Abbott is seeking a Site Quality Leader to oversee quality for the Plymouth, MN and St. Paul, MN Structural Heart facilities. You will drive the Quality Management System, regulatory compliance and a proactive quality culture across manufacturing and release processes.

Lead a team of quality professionals, align quality strategy with business goals, and prepare for regulatory inspections while ensuring product safety and regulatory readiness.

Qualifications

• Bachelor's or advanced degree in Engineering or related field.
• Minimum 12 years of Medical Device manufacturing experience including significant quality leadership roles.

Responsibilities

• Establish and implement a site quality strategy aligned with regulatory expectations.
• Represent Quality on Site Leadership Team and embed quality into decision making.
• Promote a proactive quality culture focused on risk management and continuous improvement.
• Maintain compliance with EU MDR, FDA QMSR, ISO standards and inspections readiness.
• Lead and develop the site quality organization and oversee manufacturing processes.

Skills

Quality leadership

Regulatory compliance

Risk management

Quality systems

Audits

Education

Bachelor's degree in Engineering or related field

Job description

Abbott is seeking a Site Quality Leader to oversee quality for the Plymouth, MN and St. Paul, MN Structural Heart facilities. You will drive the Quality Management System, regulatory compliance and a proactive quality culture across manufacturing and release processes.

Lead a team of quality professionals, align quality strategy with business goals, and prepare for regulatory inspections while ensuring product safety and regulatory readiness.