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 8am-4:30pm.
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.
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, 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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.