Senior Quality Audit Lead - Medical Devices

Getinge; Wayne (NJ); Sur place; USD 123 000 - 137 000; Plein temps

Avantages offerts par ce poste

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Résumé du poste

Getinge in Wayne, NJ is seeking a Staff Quality Engineer, Internal Audits, to lead complex internal audits and drive continuous quality improvements across Cardiac Assist. You will coach auditors, coordinate external inspections, and ensure timely remediation while aligning with FDA QMSR, ISO 13485, MDSAP, and EU MDR requirements.

Four days on-site in Wayne, NJ. The role requires broad experience in regulated quality systems, strong analytical skills, and collaboration with cross-functional

Qualifications

• Bachelor's degree in Engineering, Science, Quality or equivalent technical discipline.
• Eight years of progressive auditing and quality assurance experience in a regulated industry.
• Extensive medical-device quality-system auditing experience including internal and external audits.
• Certifications: ISO 13485 Lead Auditor, MDSAP Lead Auditor, EU MDR; CQAs/CQEs preferred.

Responsabilités

• Lead complex internal audits and re-audits across Cardiac Assist functions and sites.
• Define audit scope, criteria, sampling, agenda and reporting approach based on risk.
• Prepare timely, evidence-based audit reports with observations and nonconformities.
• Provide technical guidance and coaching to auditors and cross-functional teams.
• Coordinate readiness for external audits and inspections and remediation efforts.

Connaissances

Audit leadership

Regulatory knowledge

Quality system audits

Cross-functional collaboration

Communication skills

Risk assessment

Formation

Bachelor's degree in Engineering, Science, Quality

Master's degree preferred

ISO 13485 Lead Auditor Certification

MDSAP Lead Auditor Certification

EU MDR Certification

Certified Quality Auditor or CQE preferred

Description du poste

Getinge in Wayne, NJ is seeking a Staff Quality Engineer, Internal Audits, to lead complex internal audits and drive continuous quality improvements across Cardiac Assist. You will coach auditors, coordinate external inspections, and ensure timely remediation while aligning with FDA QMSR, ISO 13485, MDSAP, and EU MDR requirements.

Four days on-site in Wayne, NJ. The role requires broad experience in regulated quality systems, strong analytical skills, and collaboration with cross-functional