Specialist Role at Penumbra | BS Life Science Graduates Apply
Penumbra is seeking a dedicated Quality Monitoring & Improvement Specialist. Discover how this crucial position at Penumbra, a global healthcare innovator, helps ensure life-saving products meet the highest standards of safety and quality. This article breaks down the key responsibilities, qualifications, and what it takes to thrive in this essential role.
- Job Posting: Quality Monitoring & Improvement Specialist I
- Base Pay Range Per Hour: $32.00 – $43.00
About the Company:
Penumbra Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products addressing challenging medical conditions. The company’s broad portfolio aims to meet significant unmet medical needs. Penumbra sells its products worldwide to hospitals and healthcare providers through various channels. This job offers the opportunity to work with a team revolutionizing the treatment of severe diseases.
Education:
A Bachelor’s degree in life sciences or a related field
Experience
1+ years of quality systems experience in a regulated medical device or pharmaceutical environment
Specialist Role Job Description:
As a key member of the Quality team at Penumbra, you will be responsible for ensuring that the company’s products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will support the Quality Management System (QMS) processes, focusing on Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs), and Deviation Authorizations (DAs) in accordance with Penumbra’s procedures and regulatory requirements.
Specialist Role Key Responsibilities
- Organizes and facilitates board meetings, providing guidance to review assigned QMS process documentation and delivering regular status updates.
- Communicates with NCR/CAPA/DA owners to obtain status updates or provide reminders about upcoming due dates.
- Maintains and updates NCR/CAPA/DA tracking systems.
- Prioritizes routing QMS process documentation for approvals. Follows up with approvers if a response is not received in a reasonable timeframe.
- Collaborates and communicates cross-functionally with teams, including but not limited to Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D, and Production.
- Assists with data compilation for monthly trending meetings.
- Receives data requests (charts, graphs, etc.) and implements the changes with guidance/support.
- Supports management during internal and external audits, with guidance/support.
- Reviews quality records associated with the QMS process to ensure accuracy with the approved format and standards.
- Provides basic guidance on the assigned QMS process(es).
- Maintains control and access to quality records for the assigned QMS process.
- Cross-trains on other QMS processes and provides backup and support when needed.
Skills Required:
- Some positions may require bilingual fluency in Spanish and English.
- Experience in the medical device, pharmaceutical, biotech, or other regulated industries is desired.
- Strong oral, written, and interpersonal communication skills.
- High degree of accuracy and attention to detail.
- Proficiency with MS Word, Excel, and PowerPoint.
- Ability to create basic charts and graphs for data analysis in Excel.
- Excellent organizational, interpersonal, and verbal and written communication skills, with high attention to detail and the ability to deliver quality outputs under supervision.
- Ability to excel in a fast-paced environment.
