DHR Reviewer II

Penumbra • Roseville, CA

7d • $23 - $31 • Onsite

About The Position

The DHR Reviewer II you will play a pivotal role in maintaining the integrity of our Quality systems and processes. You will be responsible for timely and accurate support of quality processes related to Device History Records (DHRs) to ensure compliance with Penumbra procedures and regulatory requirements. This role will develop a working knowledge of applicable internal procedures.

Requirements

• A High school diploma or AA degree with 4+ years of quality systems experience in regulated device or pharmaceutical environments, or equivalent combination of education and experience
• Strong oral, written and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with Microsoft Office (e.g., Word, Excel, etc.)

Responsibilities

• Review completed DHRs in accordance with internal procedure(s) with a high level of accuracy and attention to detail.
• Reconcile finished and rejected quantities.
• Verify training for personnel listed on DHRs.
• Communicate effectively with supervisors to correct any errors or omissions in DHRs or associated documents.
• Enter DHR information into relevant databases.
• Scan, label, and file DHRs.
• Assist with DHR records retrieval as requested.
• Demonstrate mastery of Tier I level DHR Review.
• Demonstrate proficiency with Tier II level DHR Review.
• Maintain DHR files as well as access to them.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees