Quality Systems Associate: CAPA, NCR & DAs

Comunidade Metodista; Alameda (CA); On-site; USD 44,000 - 59,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid time off & holidays

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Quality Monitoring & Improvement Specialist I to support the QMS processes, CAPAs, NCRs and DAs, ensuring compliance with regulatory requirements. The role organizes board reviews, tracks statuses, and assists with data for monthly trending meetings.

Strong communication, detail orientation, 1+ year quality systems experience, and MS Office skills are essential. Join a collaborative team focused on safe, innovative medical devices, with comprehensive

Qualifications

• Bachelor's degree in engineering, life sciences, or related field with 1+ year quality systems experience.
• Bilingual Spanish/English is a plus.
• Experience in a regulated medical device or pharmaceutical environment preferred.
• Strong communication and attention to detail.
• Proficiency with MS Word, Excel, and PowerPoint.
• Ability to create basic charts and graphs in Excel.

Responsibilities

• Organizes and facilitates board meetings to review QMS documentation.
• Obtains status updates from NCR/CAPA/DA owners and tracks due dates.
• Maintains NCR/CAPA/DA tracking systems.
• Collaborates cross-functionally with Manufacturing Eng, Quality Eng, Regulatory, R&D and Production.
• Assists with data compilation for monthly trending meetings.
• Receives data requests and implements changes with guidance.
• Supports internal and external audits with guidance.
• Reviews quality records for accuracy and maintains proper records.

Skills

Quality systems experience

Communication skills

Bilingual Spanish/English

Education

Bachelor's in engineering or life sciences

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. in Alameda, CA is seeking a Quality Monitoring & Improvement Specialist I to support the QMS processes, CAPAs, NCRs and DAs, ensuring compliance with regulatory requirements. The role organizes board reviews, tracks statuses, and assists with data for monthly trending meetings.

Strong communication, detail orientation, 1+ year quality systems experience, and MS Office skills are essential. Join a collaborative team focused on safe, innovative medical devices, with comprehensive