DHR Reviewer-Day shift(G)

Flex•Austin, TX

About The Position

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 Summary: Device History Record Reviewer (DHR) position typically involves reviewing and ensuring compliance of device history records with regulatory standards and internal specifications. SHIFT: - G - 6:00am-6:00pm Thur, Fri, Sat ,every other Wed. These roles are crucial for maintaining the integrity and safety of medical devices, ensuring that all records are up-to-date and accurate.

Requirements

Requires a High School Diploma or equivalent, technical training, or equivalent experience.
Typically requires a minimum of 2 years of related experience.
Strong Knowledge in following and creating SOPs
Experience with FDA (Food and Drug Administration) Guidelines and Procedures.

Responsibilities

Review and approve DHRs for accuracy and compliance with product specifications and traceability requirements.
Certify compliance to product specifications and traceability requirements.
Ensure proper recording of deviations and non-conformance reports from the manufacturing process.
Collaborate with cross-functional teams to request corrections to DHR documentation and improve timeliness and product quality.
Participate in quality audits and continuous improvement initiatives.
Maintain accurate and compliant records according to retention requirements.
Support global facilities in meeting quality system and regulatory requirements.