DHR Reviewer-Night shift (F)

Device History Record Reviewer

Device History Record Reviewer position typically involves reviewing and ensuring compliance of device history records with regulatory standards and internal specifications.

SHIFT : F - 6 : 00pm-6 : 00am Sun, Mon, Tue, every other Sat (20% Diff).

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. These roles are crucial for maintaining the integrity and safety of medical devices, ensuring that all records are up-to-date and accurate.
• Strong Knowledge in following and creating SOPs
• Experience with FDA Guidelines and Procedures.

Qualifications :

What you'll receive for the great work you provide :

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 accessibility@flex.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).