Device History Record Reviewer

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary Job Description Shift: G Shift 6:00pm-6:00am (Thursday, Friday, Saturday every other Wednesday) 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 results Test results and acceptance criteria compliance Ensure 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 actions Identify 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 documentation Maintain 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. What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Application Deadline: Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume. Job Posting Start Date 09-09-2026 Job Posting End Date Job Category Quality Is Sponsorship Available? No Flex 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 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).