DHR Reviewer I - Temp

The DHR Reviewer 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.

What You’ll Work On

• 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 cross functional 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 proficiency with Tier I level DHR Review.

What You Contribute

• A High school diploma and at least 2+ years of quality systems experience in regulated device or pharmaceutical environments, or equivalent combination of education and experience.
• High degree of accuracy and attention to detail.
• Proficiency Microsoft Office (Word, Excel, Access, PowerPoint).
• Proficiency with MasterControl preferred.
• Strong oral, written, and interpersonal communication skills.

Working Conditions

General office environment. Willingness and ability to work on site. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed.

What We Offer

• 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, an employee stock purchase plan, 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).