QA Product Surveillance Specialist I
Company: Penumbra, Inc.
Posted on: May 31, 2021
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
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
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
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
Keywords: Penumbra, Inc., Alameda , QA Product Surveillance Specialist I, Other , Alameda, California
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