Remote | Quality Engineering & Compliance Consultant — $80–$110/hour

24-Mag•New York, NY

3d•Remote

About The Position

We are sharing a specialised part-time consulting opportunity for professionals experienced in quality engineering, regulated-industry compliance, audit preparation, CAPA workflows, verification and validation, and structured quality documentation processes. This role supports current and upcoming remote consulting opportunities focused on structured quality engineering review, compliance documentation, audit response analysis, non-conformance review, validation protocol assessment, and high-quality project execution. Selected professionals will apply their quality and compliance expertise to review realistic regulated-industry scenarios, evaluate documentation requirements, prepare structured written outputs, and support accurate, evidence-based quality workflow tasks.

Requirements

3+ years of experience in quality engineering, compliance, validation, audit preparation, regulatory quality, or related work in a regulated industry.
Experience in industries such as medical device, aerospace, automotive, pharmaceutical, biotech, manufacturing, or other compliance-heavy environments.
Familiarity with one or more standards or frameworks such as ISO 9001, ISO 13485, FDA QSR / 21 CFR 820, IATF 16949, AS9100, ISO 14971, CAPA methodology, or related quality systems.
Comfort reading and preparing quality artifacts such as NCRs, CAPAs, audit responses, V&V protocols, inspection records, quality manuals, and validation documentation.
Strong written communication skills and ability to explain quality engineering reasoning clearly.
Ability to follow structured instructions and produce evidence-based work.

Nice To Haves

ASQ CQE, CQA, Six Sigma, ISO auditor certification, regulatory affairs credential, or equivalent quality/compliance background.
Experience with CAPA methodology, root cause analysis, risk management, validation protocols, or audit response preparation.
Familiarity with IQ/OQ/PQ, V&V, inspection protocols, FDA documentation, ISO audits, or supplier quality workflows.
Experience preparing or reviewing NCRs, CAPAs, audit responses, quality records, validation packages, or inspection documentation.
Strong attention to detail in documentation-heavy and compliance-focused environments.

Responsibilities

Review quality scenarios involving non-conformance reports, CAPA documentation, containment actions, root cause analysis, corrective actions, and preventive actions.
Evaluate NCRs and CAPAs against required fields, documented evidence, process requirements, and defined quality criteria.
Support structured review of investigation records, deviation documentation, containment plans, and closure materials.
Identify missing information, documentation gaps, expected corrective steps, and quality process requirements.
Review audit preparation scenarios involving ISO, FDA, automotive, aerospace, medical device, pharmaceutical, or other regulated-industry requirements.
Evaluate audit responses against specific clauses, documented evidence, required citations, and compliance expectations.
Support structured review of quality manuals, audit findings, inspection responses, and compliance documentation.
Prepare clear written explanations for quality and compliance decisions based on source materials and defined criteria.
Review verification and validation scenarios involving inspection protocols, IQ/OQ/PQ documentation, acceptance criteria, test evidence, and pass/fail outcomes.
Evaluate V&V protocols against defined requirements, documented results, and quality standards.
Support structured review of inspection records, validation documentation, risk controls, and test outcomes.
Maintain accuracy, consistency, and professional judgment across submitted work.