Quality Auditor Contract / Ad Hoc Support

About MDC AssociatesMDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.

Role OverviewWe are seeking an experienced, independent Quality Auditor to provide ad hoc Internal Quality Audit (IQA) support on a contract basis. The ideal candidate brings deep expertise in FDA and ISO quality systems, has hands-on lead auditor experience, and is comfortable stepping into client engagements with minimal ramp-up time.

Key Responsibilities

Plan, conduct, and report on internal quality audits (IQA) in accordance with ISO 19011 and applicable regulatory standards

Perform gap assessments against FDA QSR (21 CFR Part 820), ISO 13485, ISO 9001, and other applicable frameworks

Support Mock QSIT, Mock BIMO, and Mock PMA Pre-Approval Inspection audits

Identify non-conformances, document findings, and support CAPA development and follow-up

Conduct supplier and subcontractor audits (second and third party) as needed

Support clients during FDA and Notified Body inspections

Deliver audit reports, findings summaries, and corrective action guidance to client stakeholders

Provide training and coaching to client teams on GMP, audit readiness, and quality system requirements

Required Qualifications

ASQ Certified Quality Auditor (CQA) or equivalent certification

Exemplar Global or ANSI-RAB accredited Lead Auditor certification (ISO 13485 or ISO 9001)

Minimum 8–10 years of quality systems and audit experience in medical device, life sciences, or healthcare

Hands-on experience with FDA QSR (21 CFR Parts 820, 803, 806), ISO 13485, ISO 14155, ISO 9001, and ISO 19011

Experience conducting or supporting FDA BIMO and/or QSIT inspections

Strong written and verbal communication skills; ability to present findings clearly to senior stakeholders

Ability to work independently with minimal oversight across multiple client engagements

Preferred Qualifications

Experience with EU MDR / MDD and MDSAP

Familiarity with ISO 14971, IEC 62304, ISO/IEC 27001

Clinical quality audit experience (EDC, eTMF supplier audits)

eQMS experience (MasterControl, Veeva Vault, QT9, Arena, or similar)

Experience supporting international audits (Europe, Asia, Middle East)

Engagement Details

Project-based and ad hoc engagements; hours vary by client need

Remote work with travel to client sites as required

Competitive hourly or day-rate compensation commensurate with experience

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