Lead Quality Auditor, Internal Audits for Medical Devices

Financeroles; North Carolina; On-site; USD 123,000 - 137,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ seeks a Staff Quality Engineer, Internal Audits, to lead advanced audits under FDA QMSR, ISO, EU MDR, and MDSAP, coordinating with Manufacturing, QA, R&D, and Regulatory Affairs.

The role requires coaching auditors, driving quality-system improvements, and readiness for external inspections. The ideal candidate has 8+ years in medical-device auditing and certifications such as Lead Auditor or CQE.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or equivalent.
• Master’s degree preferred; relevant certifications valued.
• ISO13485, EU MDR, MDSAP knowledge and lead auditor experience.

Responsibilities

• Plan, lead, conduct, document, and follow up on complex internal audits.
• Serve as lead auditor for high-complexity or cross-functional audits.
• Prepare clear audit reports with observations and nonconformities.
• Ensure containment, investigation, corrective actions, and timely closure.

Skills

Auditing

Regulatory compliance

Quality-assurance

Leadership

Cross-functional collaboration

Risk-based thinking

Documentation & reporting

Communication

Education

Bachelor's degree in Engineering/Science/Quality

Master's degree preferred

Lead Auditor Certifications (ISO13485, MDSAP)

Certified Quality Auditor or CQE preferred

Tools

Microsoft Office

Audit management software

Electronic quality management systems

Job description

Getinge in Wayne, NJ seeks a Staff Quality Engineer, Internal Audits, to lead advanced audits under FDA QMSR, ISO, EU MDR, and MDSAP, coordinating with Manufacturing, QA, R&D, and Regulatory Affairs.

The role requires coaching auditors, driving quality-system improvements, and readiness for external inspections. The ideal candidate has 8+ years in medical-device auditing and certifications such as Lead Auditor or CQE.