Quality Specialist / Product Surveillance Penumbra, Inc.
THIS JOB HAS EXPIRED Job DescriptionUnder general supervision, receive, evaluate, and respond to customer comments and complaints related to products distributed by Penumbra. Responsible for timely and accurate support of quality processes related to post-market complaints to ensure compliance with all applicable procedures and regulatory requirements. This requires developing a working knowledge of applicable domestic and international regulations as well as an expertise in internal procedures and reporting systems.
?Work with teams to define and categorize potential complaints and reportable events
?Ensure that any necessary reporting and communication occurs in an appropriate and timely manner
?Support periodic trend analysis, as well as decisions and recommendations associated with corrective or preventive actions, and risk analysis
?Coordinate product return receiving and processing
?Maintain accurate and timely correspondence and data entry
?Assist with periodic audits of records and files to ensure that appropriate procedures have been followed
Requires high school diploma and three to five years of quality systems experience in a regulated device or pharmaceutical environment, or an equivalent combination of education and experience. Also required are a keen attention to detail, excellent organization skills and the ability to juggle multiple tasks. Computer skills and strong written and verbal communication skills required.
||Alameda, CA |
THIS JOB HAS EXPIRED