Contract position for a Validation Engineer supporting quality-system remediation at a medical device manufacturer.
Assess product and process risk and drive corrective action tied to regulatory findings and open quality records.
Perform or refresh hazard analyses and design/process FMEAs to rank product, process, and complia nce risk.
Review regulatory observations, CAPAs, investigations, complaints etc. to locate gaps in root-cause analysis, risk controls, traceability, and objective evidence.
Build a risk-based remediation plan mapping findings and CAPA commitments to root causes, corrective actions, verification activities, owners, and due dates.
Draft or revise CAPA records spanning problem definition, containment, investigation strategy, root-cause analysis, corrections, and effectiveness checks.
Determine when design, process, supplier, or CAPA changes trigger additional verification or validation, and define the test plans, protocols, acceptance criteria, and traceability required.
Assemble inspection-ready documentation and evidence packages for regulatory review, management review, and audit.
Facilitate cross-functional sessions across Product Development, Quality, Regulatory, and Manufacturing, report weekly on deliverables and open risks, and deliver a final status report and knowledge-transfer handoff.
Requirements
BS Engineering.
Minimum 7 years of experience with risk management, CAPA remediation, design controls, and verification and validation (V&V) Working knowledge of design controls, risk management, requirements and traceability management, and good documentation practices.
Experience authoring or updating hazard analyses, design and process FMEAs, risk-control measures, and risk-management reports.
Experience judging the V&V impact of design, process, supplier, or CAPA changes and generating technically defensible objective evidence.
Strong technical writing skills with a track record of clear, inspection-ready documentation.
Ability to work independently, manage competing priorities, and challenge assumptions constructively.
Experience with document-control, CAPA, requirements-management, or electronic quality (eQMS) systems a plus.
