QA Product Surveillance Specialist I

Company: Penumbra
Location: Alameda
Posted on: June 6, 2021

Job Description:

As a key member of our Quality Assurance team, you will have a hand in ensuring that Penumbra's life-saving products adhere to the highest standards of quality and safety. By providing timely and accurate support of quality processes related to customer comments and complaints, you will help ensure that we are in compliance with all applicable procedures and regulatory requirements.

What You'll Work On

• Receive, evaluate, and respond to comments and complaints related to products distributed by Penumbra.
• Develop a working knowledge of applicable domestic and international regulations as well as an expertise in internal procedures and reporting systems.
• Coordinate product return receiving and processing.
• Categorize potential complaints and reportable events.
• Support management during inspections and audits.
• Provide guidance and training to other staff on product surveillance issues and procedures.
• Maintain accurate and timely correspondence and data.
• Coordinate periodic audits of records and files to ensure that appropriate procedures have been followed.

What You Bring

• A keen attention to detail and a high level of accuracy in your work.
• Bachelor's or Associate's degree in the life sciences, plus 1+ years of Medical Device, Pharma, or Diagnostics experience, or an equivalent combination of education and experience.
• Medical device experience strongly preferred.
• Excellent oral, written, and interpersonal communication skills.

What We Offer

• A collaborative teamwork environment where learning is constant and performance is rewarded.
• The opportunity to be part of the team whose technology is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.

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, disability or protected veteran status.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

Keywords: Penumbra, Alameda , QA Product Surveillance Specialist I, Other , Alameda, California