About The Position
Device History Record Reviewer (DHR) position typically involves reviewing and ensuring compliance of device history records with regulatory standards and internal specifications. 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 (Food and Drug Administration) Guidelines and Procedures.
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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
