Hybrid Senior Quality Auditor, Internal Audits

Getinge; Wayne (NJ); On-site; USD 123,000 - 137,000; Full time

Benefits offered by this job

Health insurance

401k plan

Paid Time Off

Wellness program

Life Insurance

Short/Long Term Disability

Flex spending accounts

Parental Leave

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ is seeking a Staff Quality Engineer, Internal Audits to lead complex audits and drive regulatory compliance across Cardiac Assist functions. You will plan, execute, and report on risk-based audits, coach auditors, and partner with cross-functional teams to strengthen quality-system controls.

The role requires eight+ years in regulated industries, deep knowledge of FDA QMSR, ISO 13485, EU MDR/MDD, and related standards.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or equivalent.
• Eight years of progressive auditing/quality- assurance experience in a regulated industry.
• Substantial medical-device quality-system auditing experience including internal/external audits.
• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) preferred.

Responsibilities

• Plan, lead, conduct, document, and follow up on complex internal audits and re-audits.
• Lead high-complexity or cross-functional audits with defined scope and reporting.
• Prepare timely, evidence-based audit reports with observations and nonconformities.
• Ensure containment, investigation, and timely closure of audit findings and CAPAs.
• Provide technical guidance to auditors and support cross-functional teams.

Skills

Auditing

Quality systems

Regulatory knowledge

Leadership

Data analysis

Education

Bachelor's degree

Master's degree preferred

Tools

Microsoft Office

Quality management software

Audit management software

Job description

Getinge in Wayne, NJ is seeking a Staff Quality Engineer, Internal Audits to lead complex audits and drive regulatory compliance across Cardiac Assist functions. You will plan, execute, and report on risk-based audits, coach auditors, and partner with cross-functional teams to strengthen quality-system controls.

The role requires eight+ years in regulated industries, deep knowledge of FDA QMSR, ISO 13485, EU MDR/MDD, and related standards.