Quality Monitoring & Improvement Specialist I

Penumbra • Alameda, CA

3d • Onsite

About The Position

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.

Requirements

• A Bachelor's degree preferably in engineering, life sciences, or a related field with 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience.
• 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.

Nice To Haves

• Bilingual Spanish/English fluency is a plus
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired

Responsibilities

• 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.

Benefits

• medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level