The DHR Reviewer 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. Hours for this role would be 12pm-8:30pm.
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.
Base Pay Range Per Hour: $22.00 – $32.00 / hour
Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.