Quality Monitoring & Improvement Specialist I

As a key member of the Quality team, you will have a hand in ensuring that Penumbra's life-saving products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will be supporting our Quality Management System (QMS) processes, specifically Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs) and Deviation Authorizations (DAs) following Penumbra's procedures and regulatory requirements. You will organize and host board meetings to facilitate board review of documentation supporting these systems. You will also assist with data compilation for monthly trending meetings.

What You'll Work On

• Organizes and facilitates board meetings with guidance to review assigned QMS process documentation, giving 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 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 of quality records for the assigned QMS process.
• Cross trains on other QMS processes and provides backup and support when needed.

What You Contribute

Working Conditions General office environments. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception. Base Pay Range Per Hour : $32.00 - 43.00 / hour Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

What We Offer