Quality Manager, Medical Devices - Lead Quality Ops

Abbott Laboratories; Westfield (IN); On-site; USD 113,000 - 227,000; Full time

Benefits offered by this job

HIP PPO health plan

Strong retirement plan

Tuition reimbursement

Job summary

Abbott Laboratories in Westfield, IN, part of the Structural Heart division, seeks a Quality Manager to lead the Quality Operations Organization, directing supervisors, technicians, inspectors, and specialists to ensure compliant, high‑quality manufacturing, supplier development, and new product introductions.

You will drive CAPA, regulatory compliance (FDA/BSI), budgets, staff development, and data-driven improvements, partnering with engineering, operations, and external auditors to advance

Qualifications

• B.S. in Engineering or related field.
• 8–10 years in manufacturing quality roles.
• 3–5 years in supervisory/leadership.
• Experience with nonconformance, risk reduction, and cost containment.
• Strong project management and leadership capabilities.

Responsibilities

• Implements staffing plans and coordinates HR approvals.
• Develops direct reports through training and performance reviews.
• Monitors daily operations to meet goals.
• Interacts with internal and external stakeholders.
• Manages CAPA activities and quality systems improvements.
• Supports internal and external audits.

Skills

Project management

Leadership

Quality systems

Regulatory compliance

Strategic thinking

Education

B.S. in Engineering

Job description

Abbott Laboratories in Westfield, IN, part of the Structural Heart division, seeks a Quality Manager to lead the Quality Operations Organization, directing supervisors, technicians, inspectors, and specialists to ensure compliant, high‑quality manufacturing, supplier development, and new product introductions.

You will drive CAPA, regulatory compliance (FDA/BSI), budgets, staff development, and data-driven improvements, partnering with engineering, operations, and external auditors to advance