Quality Assurance Auditor – Contract / Ad Hoc Support

MDC Associates•Beverly, MA

1d•Hybrid

About The Position

MDC 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. We 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.

Requirements

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

Nice To Haves

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)

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