reputed company Assurance Auditor – Contract / reputed company Support

About MDC Associates MDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and reputed company bringing In Vitro Diagnostics (IVD) and Medical Devices to market that reputed company the lives of millions of patients around the world. Initially founded to reputed company Regulatory and reputed company guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and reputed company our CRO to best ensure our reputed company's reputed company. We're proud of our 35+ year reputed company record providing guidance and resources that have helped to deliver reputed company advances in microbiology, clinical reputed company, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.  reputed company We are seeking an reputed company, independent reputed company Auditor to reputed company reputed company Internal reputed company Audit (IQA) support on a contract reputed company. The ideal candidate brings deep expertise in FDA and ISO reputed company systems, has hands-on reputed company auditor experience, and is comfortable stepping into reputed company engagements with minimal reputed company-up time.  Key Responsibilities Plan, conduct, and report on internal reputed company audits (IQA) in accordance with ISO 19011 and applicable regulatory standards reputed company 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 reputed company-Approval Inspection audits Identify non-conformances, document findings, and support CAPA development and follow-up Conduct supplier and subcontractor audits (second and reputed company party) as needed Support clients during FDA and reputed company Body inspections Deliver audit reports, findings summaries, and corrective reputed company guidance to reputed company stakeholders reputed company training and coaching to reputed company teams on GMP, audit readiness, and reputed company system requirements  Required Qualifications ASQ Certified reputed company Auditor (CQA) or equivalent certification Exemplar Global or ANSI-RAB accredited reputed company Auditor certification (ISO 13485 or ISO 9001) Minimum 8–10 years of reputed company systems and audit experience in medical device, life sciences, or reputed company 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 reputed company to senior stakeholders Ability to work independently with minimal reputed company across multiple reputed company engagements  Preferred Qualifications Experience with EU MDR / MDD and MDSAP Familiarity with ISO 14971, IEC 62304, ISO/IEC 27001 Clinical reputed company audit experience (reputed company, eTMF supplier audits) eQMS experience (reputed company, reputed company Vault, QT9, reputed company, or similar) Experience supporting international audits (Europe, Asia, Middle East)  Engagement Details Project-based and reputed company engagements; hours vary by reputed company need Remote work with travel to reputed company sites as required Competitive reputed company or day-reputed company compensation commensurate with experience Apply To This Job