Quality Monitoring & Improvement… at Penumbra, Inc. · Alameda

Summary: Penumbra is a global healthcare company focused on innovative therapies, and they are seeking a Quality Monitoring & Improvement Specialist I to support their Quality Management System processes. The role involves organizing board meetings, maintaining tracking systems, and collaborating with cross-functional teams to ensure compliance with quality standards. 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 Required Qualifications: - 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 Preferred Qualifications: - Bilingual Spanish/English fluency is a plus - Medical device, pharmaceutical, biotech, or other regulated industry experience desired Required Skills: Quality Management System (QMS), Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs), Deviation Authorizations (DAs), Regulatory requirements in medical device or pharmaceutical industry, Data analysis with Excel, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Medical device industry experience, Pharmaceutical industry experience, Biotech industry experience 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, Paid sick time in compliance with applicable law(s)