QA Documentation Specialist II | Document Control & Compliance

Penumbra, Inc.; Alameda (CA); On-site; USD 39,000 - 48,000; Full time

Job summary

Penumbra, Inc. in Alameda, CA, is seeking a QA Document Specialist II to support quality processes and ensure regulatory compliance for Penumbra documentation.

You will process Engineering Change Orders, verify English usage and formatting, and maintain controlled documents and records on site. The role requires strong written/verbal communication, attention to detail, and experience with standard office software.

Qualifications

• A high school graduate or AA degree with 2+ years of quality systems experience in regulated device or pharmaceutical environments, or an equivalent combination of education and experience.
• Bachelor's degree is strongly preferred
• Excellent and precise written and verbal communication and organizational skills.
• Knowledge of standard office software packages.
• Experience with data entry.
• Excellent attention to detail.
• Understanding of customer service.

Responsibilities

• Precisely and efficiently process Engineering Change Orders
• Verify and correct English usage and Penumbra formatting in controlled documents.
• Communicate effectively with all levels of organization in processing Engineering Change Orders, maintaining the accuracy and integrity of all Penumbra controlled documentation
• Maintain up-to-date paper and electronic file records
• Assist in internal and external audits as key backroom support
• Assist in other areas including device history review and International Certificate of Compliance
• Performs duties required by the Quality System and other duties as assigned or requested

Skills

Written communication

Verbal communication

Organizational skills

Data entry

Attention to detail

Customer service

Education

HS diploma or AA

Bachelor's degree

Tools

Microsoft Office

Job description

Penumbra, Inc. in Alameda, CA, is seeking a QA Document Specialist II to support quality processes and ensure regulatory compliance for Penumbra documentation.

You will process Engineering Change Orders, verify English usage and formatting, and maintain controlled documents and records on site. The role requires strong written/verbal communication, attention to detail, and experience with standard office software.