Quality Assurance Auditor – Contract / Ad Hoc Support at MDC Associates

Beverly, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jul, 26

Salary

0.0

Posted On

26 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Auditing, ISO 13485, FDA QSR, ISO 19011, Gap Assessment, CAPA Development, Supplier Audits, Regulatory Compliance, Medical Devices, In Vitro Diagnostics, GMP, Audit Readiness, ISO 9001, ISO 14155, Quality Systems, Lead Auditor

Industry

Medical Equipment Manufacturing

Description

About MDC Associates 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. Role Overview 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. 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

Responsibilities

The Quality Assurance Auditor will plan, conduct, and report on internal quality audits in accordance with ISO 19011 and regulatory standards. They will also perform gap assessments, support mock inspections, and provide guidance on corrective actions and quality system requirements.