Job Description
As a member of Penumbra’s Quality Assurance team, you will participate in the development and implementation of processes and strategies designed ensure compliance with our quality policy and regulatory requirements.
You will: Apply your knowledge of domestic and international regulations, and internal procedures and reporting systems to independently solve problems. Coordinate the training and certification of Quality Control inspectors Support the product evaluation team, tracking and categorizing potential complaints and reportable events Ensure that any necessary reporting and communication occurs in an appropriate and timely manner Coordinate product return receiving and processing Maintain accurate and timely correspondence and data entry Coordinate periodic audits of records and files to ensure that appropriate procedures have been followed Support management during FDA inspections and notified body audits Interface with other internal departments, customers, and suppliers on quality-related issues Skill set We require a Bachelor's degree and one year of Quality Assurance experience in a medical device, biotechnology or pharmaceutical environment, or an equivalent combination of education and experience. Excellent written, verbal and interpersonal communication skills; proficiency with Microsoft Office tools and mathematics; organization and keen attention to detail are also required. |
Job Application Accepted Via Email: deborah.bain@penumbrainc.com
