Device History Record Reviewer

Device History Record ReviewerThe Device History Record Reviewer will be based in Austin, TX, reporting to Quality Supervisor. In charge of performing product inspection and/or audits of quality control programs, first article inspections and calibration, inspecting flat blank layouts, out of box audit (OBA) and sampling and testing of incoming components and raw materials. Purge material. Ensures raw materials, in process and finished products meet company standards. General documentations updated (Quality alerts).Responsibilities:Perform comprehensive review of Device History Records (DHRs) to ensure completeness, accuracy, and compliance with approved procedures, Device Master Record (DMR), and regulatory requirements (e.g., FDA 21 CFR 820.184, ISO 13485).Verify all required manufacturing and quality records are present, including:Traceability documentation (lot numbers, serial numbers, components)In-process and final inspection resultsTest results and acceptance criteria complianceEnsure no discrepancies, missing data, or documentation errors exist prior to product release.Support or execute final product release decisions based on DHR review outcomes.Ensure all entries within the DHR adhere to Good Documentation Practices (GDP) requirements, Legibility, accuracy, and completeness, corrections.Real-time documentation and traceability of actionsIdentify and escalate data integrity issues and support remediation.Identify documentation errors, nonconformances, or deviations during DHR review.Support Nonconformances (NCs), deviation documentation.Ensure discrepancies are fully investigated, documented, and approved prior to DHR closure.Verify that corrective actions are implemented and properly documented within the record.Verify full end-to-end traceability of materials and components like matching quantities and correct association to work orders and finished goods.Perform reconciliation activities to ensure that all components are accounted for and documented accurately.Ensure DHRs are inspection-ready at all times for internal audits, FDA inspections, and customer audits.Support audit activities by retrieving and explaining DHR documentationMaintain compliance with internal quality systems and external regulatory standards.Cross-functional Collaboration with Manufacturing, Quality Engineering and Document Control.Provide feedback on documentation errors and trends to drive continuous improvement.Support training efforts to improve documentation accuracy and compliance.Track and report DHR review metrics such as Right-first-time, Common documentation errors and review turnaround time.Identify recurring issues and support process improvements to enhance efficiency and compliance.Utilize electronic Quality Management Systems (eQMS) and/or ERP systems to: Review, approve DHRs, and ensure version control of documents.Maintain proper documentation filing and archival practices per retention requirements.Provide real-time support to manufacturing to prevent documentation errors before they occur.Ensure proper use of forms and adherence to approved procedures on the production floor.Qualifications:Requires a High School Diploma or equivalent, technical training, or equivalent experience.Typically requires a minimum of 5 years of related experience.What you'll receive for the great work you provide:Full range of medical, dental, and vision plansLife InsuranceShort-term and Long-term DisabilityMatching 401(k) ContributionsVacation and Paid Sick TimeTuition ReimbursementJob Category: QualityIs Sponsorship Available? NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email View email address on apply.j-vers.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).