QA Document Specialist I - Temp
Penumbra
Summary
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.
Job description
What You’ll Work On
- 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
What You Contribute
- 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.
- Bachelor's degree is strongly preferred
- Excellent and precise written and verbal communication and organizational skills.
- Knowledge of standard office software packages.
- Experience with data entry.
- Excellent attention to detail.
- Understanding of customer service.
Working Conditions
General office, production, laboratories, and controlled environment facility. Willingness and ability to work on site. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with Penumbra employees at all levels on a daily basis.
Requirements
- 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.
- Bachelor's degree is strongly preferred
- Excellent and precise written and verbal communication and organizational skills.
- Knowledge of standard office software packages.
- Experience with data entry.
- Excellent attention to detail.
- Understanding of customer service.
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Paid Parental Leave
- Paid Company Holidays
- Paid Vacation
- Paid Sick Time
Company overview
Penumbra, Inc. is a global medical device company headquartered in Alameda, California, specializing in innovative interventional therapies for challenging vascular conditions. Founded in 2004 by Arani Bose and Adam Elsesser, the company has established itself as the world's leading thrombectomy company, focusing on developing advanced technologies for ischemic stroke, pulmonary embolism, and acute limb ischemia treatment. Penumbra's flagship technology is Computer Assisted Vacuum Thrombectomy (CAVT), a revolutionary platform that combines sophisticated algorithms with maximum aspiration power to enable rapid, safe, and effective blood clot removal. The company's product portfolio includes the Lightning Flash, Lightning Bolt, and Penumbra ENGINE systems, which are designed to address thrombus removal from head-to-toe with unprecedented speed and precision. Operating in over 100 countries, Penumbra supports healthcare providers through its direct sales organization and distributor networks, consistently delivering clinical innovations that improve patient outcomes and reduce healthcare costs. As a publicly traded company on the NYSE (PEN) with approximately 4,200 employees, Penumbra continues to pioneer advancements in endovascular care while maintaining a strong commitment to research and development in the medical device sector.