Device History Record Reviewer

Quality Assurance 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

Shift: E Shift 6:00am-6:00pm (Sunday, Monday, Tuesday 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.
• Verify all required manufacturing and quality records are present, including traceability documentation, 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.
• 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

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 View email address on click.appcast.io and we'll discuss your specific situation and next steps.