Senior Director, Cardiac Quality & Compliance

Getinge; Wayne (NJ); On-site; USD 238,000 - 275,000; Full time

Benefits offered by this job

Annual bonus 35%

Getinge Fleet/Company Vehicle Program

Job summary

Getinge is seeking a Senior Director, Quality & Compliance to lead the Quality and Compliance team within Cardiac Assist product area. The role provides strategic leadership across QMS, Design and Production Quality Engineering, Quality Control and Regulatory compliance.

Onsite 4 days a week, you will drive quality system performance, regulatory readiness, and continuous improvement while partnering with cross-functional teams to ensure patient safety and product quality across the enterprise.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field required.
• Master's degree preferred.
• 15+ years in Quality Assurance/Quality Systems in the medical device industry.
• 5+ years in a senior leadership role at Director level or above.

Responsibilities

• Develop and lead a high-performing Quality organization aligned with objectives.
• Establish and maintain quality systems, regulatory compliance and CAPA programs.
• Lead audits, supplier quality and risk management activities.
• Collaborate with cross-functional teams to drive quality improvements.

Skills

Quality leadership

Regulatory compliance

Quality Systems

Auditing

Risk management

Cross-functional leadership

FDA regulations

Education

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

Master's degree preferred

Tools

Microsoft Office

Job description

Getinge is seeking a Senior Director, Quality & Compliance to lead the Quality and Compliance team within Cardiac Assist product area. The role provides strategic leadership across QMS, Design and Production Quality Engineering, Quality Control and Regulatory compliance.

Onsite 4 days a week, you will drive quality system performance, regulatory readiness, and continuous improvement while partnering with cross-functional teams to ensure patient safety and product quality across the enterprise.