QA Document Specialist I - Temp

Penumbra•Alameda, CA

1d•Onsite

About The Position

As a QA Document Specialist II, you will play a pivotal role at Penumbra providing timely and accurate support of quality processes related to Document Services to ensure compliance with Penumbra procedures and regulatory requirements. Following standards and procedures and analyzing data, you will develop knowledge of Penumbra processes and external regulations to make independent decisions.

Requirements

A high school graduate or AA degree with 2+ years of quality systems experience in regulated device or pharmaceutical environments, or an equivalent combination of education and experience.
Knowledge of standard office software packages.
Experience with data entry.
Excellent attention to detail.
Understanding of customer service.

Nice To Haves

Bachelor's degree is strongly preferred
Excellent and precise written and verbal communication and organizational skills.

Responsibilities

Precisely and efficiently process Engineering Change Orders
Verify and correct English usage and Penumbra formatting in controlled documents. This includes, but is not limited to, correct spelling, punctuation, and accurate word usage
Communicate effectively with all levels of organization in processing Engineering Change Orders, maintaining the accuracy and integrity of all Penumbra controlled documentation
Maintain up-to-date paper and electronic file records
Assist in internal and external audits as key backroom support
Assist in other areas including device history review and International Certificate of Compliance
Performs duties required by the Quality System and other duties as assigned or requested

Benefits

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
paid sick time in compliance with applicable law(s)