Quality Assurance Auditor

Regulatory Affairs Consultant – Contract / Ad Hoc SupportAbout 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 Assurance 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 ResponsibilitiesPlan, conduct, and report on internal quality audits (IQA) in accordance with ISO 19011 and applicable regulatory standardsPerform gap assessments against FDA QSR (21 CFR Part 820), ISO 13485, ISO 9001, and other applicable frameworksSupport Mock QSIT, Mock BIMO, and Mock PMA Pre-Approval Inspection auditsIdentify non-conformances, document findings, and support CAPA development and follow-upConduct supplier and subcontractor audits (second and third party) as neededSupport clients during FDA and Notified Body inspectionsDeliver audit reports, findings summaries, and corrective action guidance to client stakeholdersProvide training and coaching to client teams on GMP, audit readiness, and quality system requirementsRequired QualificationsASQ Certified Quality Auditor (CQA) or equivalent certificationExemplar 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 healthcareHands-on experience with FDA QSR (21 CFR Parts 820, 803, 806), ISO 13485, ISO 14155, ISO 9001, and ISO 19011Experience conducting or supporting FDA BIMO and/or QSIT inspectionsStrong written and verbal communication skills; ability to present findings clearly to senior stakeholdersAbility to work independently with minimal oversight across multiple client engagementsPreferred QualificationsExperience with EU MDR / MDD and MDSAPFamiliarity with ISO 14971, IEC 62304, ISO/IEC 27001Clinical 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 DetailsProject-based and ad hoc engagements; hours vary by client needRemote work with travel to client sites or clinical study locations as requiredCompetitive hourly or project-rate compensation commensurate with experience