Principal Quality Internal Auditor

Getinge•Wayne, NJ

2d•Onsite

About The Position

The Principal Quality Auditor plays a vital role in leading and participating in internal and external audits within the medical device industry. This position ensures compliance with medical device regulations including, but not limited to ISO 13485, ISO 14971, 21 CFR Part 820. The auditor brings expert knowledge from prior roles leading audits and driving compliance improvements, risk management, and regulatory adherence. The position requires strong leadership in audit planning, execution, reporting, and follow-up, as well as mentoring audit teams and liaising with regulatory agencies.

Requirements

Bachelor’s degree in Engineering, Science, or equivalent; advanced degree preferred.
Minimum of 7 years of quality auditing experience in the medical device industry, including direct audit leadership at FDA or Notified Bodies preferred.
Deep expertise in ISO 13485, ISO 14971, and 21 CFR Part 820 regulations.
Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred.
Proven experience in planning, conducting, and leading regulatory audits and inspections.
Strong knowledge of risk management principles and medical device regulatory reporting requirements.
Excellent ability to analyze complex quality systems and processes and identify compliance gaps.
Strong communication skills to effectively present audit results and influence corrective action implementation.
Proficiency with quality management software tools and Microsoft Office.

Nice To Haves

advanced degree preferred
direct audit leadership at FDA or Notified Bodies preferred
Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred

Responsibilities

Lead and execute comprehensive audits of quality systems and processes to ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, etc.
Participate in and lead FDA and Notified Body audits, including audit planning, execution, reporting, and corrective action follow-up.
Evaluate Quality Management Systems (QMS) for effectiveness, regulatory compliance, and risk management integration.
Assess and verify compliance with risk management standards (ISO 14971) and reporting requirements (21 CFR Part 803 Medical Device Reporting).
Conduct audits on various QMS elements such as design controls, complaint handling, CAPA systems, supplier controls, and production processes.
Review and approve audit reports, findings, and CAPA plans to ensure timely and effective resolution of nonconformities.
Provide training and mentorship to internal audit teams to build auditor competency and ensure consistency.
Collaborate with cross-functional teams (Regulatory Affairs, QA, R&D, Manufacturing) to drive audit readiness and regulatory compliance.
Serve as a subject matter expert representing the company during regulatory inspections and notified body assessments.
Maintain up-to-date knowledge of regulatory changes and communicate their impact on quality systems and audit processes.
Facilitate internal audits and risk assessments to support continuous improvement and regulatory compliance readiness.
Support management review activities by providing audit findings and quality metrics relevant to compliance status.