DHR Reviewer I (Medtech)

TL;DR

DHR Reviewer I (Medtech): Maintaining the integrity of quality systems and processes by reviewing Device History Records (DHRs) with an accent on regulatory compliance and accuracy. Focus on reconciling quantities, verifying personnel training, and coordinating corrections with cross-functional supervisors.

Location: Onsite in Alameda, CA

Salary: $22.00 – $32.00 / hour

Company

Global healthcare company focused on designing, developing, and manufacturing innovative therapies for challenging medical conditions.

What you will do

• Review completed Device History Records (DHRs) with a high level of accuracy and attention to detail.
• Reconcile finished and rejected quantities.
• Verify training records for personnel listed on DHRs.
• Collaborate with cross-functional supervisors to correct errors or omissions in documentation.
• Perform data entry into relevant databases and handle scanning, labeling, and filing of records.

Requirements

• High school diploma.
• 2+ years of quality systems experience in regulated device or pharmaceutical environments.
• Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint).
• Must be able to work on site in Alameda, CA.
• Ability to lift and move up to 25 pounds and navigate between office buildings.

Nice to have

• Proficiency with MasterControl.

Culture & Benefits

• Collaborative teamwork environment with a focus on constant learning.
• Comprehensive benefits for eligible employees, including medical, dental, vision, life, and disability insurance.
• 401(k) plan with employer match.
• Paid parental leave, eleven paid company holidays, and accrued vacation/sick time.