Quality Leader for Implantable Medical Devices

Actalent; Maple Grove (MN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending Account (FSA)

Basic Life

401(k) Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

Actalent is seeking a Quality Manager to lead quality operations for a Class III implantable medical device program based in Maple Grove, MN. You will oversee manufacturing quality, inspections, investigations, and quality systems, guiding a team of quality professionals toward regulatory readiness and operational excellence.

The role emphasizes leadership, CAPA-driven improvements, and collaboration across clinical, regulatory, and commercialization activities to bring cardiovascular therapies

Qualifications

• Bachelor's degree in engineering, life sciences, quality, or a related technical discipline.
• 7+ years in Quality Engineering, QA, Manufacturing Quality, or Quality Operations in a regulated industry.
• Experience in FDA-regulated medical device manufacturing environments.
• Strong knowledge of quality systems, CAPA, nonconformance, root cause analysis, and regulatory compliance.
• Experience leading investigations and driving corrective and preventive actions.
• Prior people leadership or team management experience.
• Strong understanding of manufacturing quality, inspection methods, process controls, and quality improvement methodologies.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead quality operations supporting manufacturing, inspection, testing, and release activities.
• Ensure compliance with FDA, ISO 13485, MDSAP, and applicable international regulations.
• Maintain a continuous state of audit and inspection readiness.
• Lead investigations involving nonconformances, deviations, complaints, and quality events.
• Drive CAPA activities from investigation through implementation and effectiveness verification.
• Partner with manufacturing teams to improve process capability, product quality, and operational performance.
• Oversee environmental monitoring, cleanroom controls, and manufacturing quality processes.
• Support supplier quality initiatives, including supplier corrective actions and incoming inspection strategies.
• Develop and coach quality engineers and quality inspectors while fostering a culture of accountability and continuous improvement.
• Monitor quality metrics and identify opportunities to improve efficiency, compliance, and product quality.
• Collaborate across functions to support clinical, regulatory, and commercialization objectives.
• Contribute to long-term quality strategy while remaining actively involved in day-to-day operations.

Skills

Quality systems

CAPA

Root cause analysis

Regulatory compliance

Investigations

People leadership

Cross-functional collaboration

Manufacturing quality

Communication

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related field

Job description

Actalent is seeking a Quality Manager to lead quality operations for a Class III implantable medical device program based in Maple Grove, MN. You will oversee manufacturing quality, inspections, investigations, and quality systems, guiding a team of quality professionals toward regulatory readiness and operational excellence.

The role emphasizes leadership, CAPA-driven improvements, and collaboration across clinical, regulatory, and commercialization activities to bring cardiovascular therapies