QA Documentation Specialist — Growth & Compliance

Lever, Inc.; Alameda (CA); On-site; USD 80,231,000 - 100,289,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life and AD&D insurance

401(k) with employer match

Paid parental leave

11 company holidays

Vacation time (min 15 days)

Paid sick time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a QA Document Specialist II to support quality processes and regulatory compliance. You will process Engineering Change Orders, verify English usage and Penumbra formatting, and communicate with all levels to maintain document integrity.

The role requires a high school diploma or AA with 2+ years in regulated environments; a Bachelor's degree is preferred. Strong writing, attention to detail, and data-entry skills are essential.

Qualifications

• 2+ years of quality systems experience in regulated device or pharmaceutical environments.
• Bachelor's degree strongly preferred.
• Excellent and precise written and verbal communication and organizational skills.
• Experience with data entry.
• Knowledge of standard office software.
• Understanding of customer service.

Responsibilities

• Process Engineering Change Orders precisely and efficiently.
• Verify and correct English usage and Penumbra formatting in controlled documents.
• Communicate with all levels to maintain accuracy and integrity of Penumbra documentation.
• Maintain up-to-date paper and electronic file records.
• Assist in internal and external audits as backroom support.
• Assist in device history review and International Certificate of Compliance.
• Perform duties required by the Quality System.

Skills

Excellent written & verbal comms

Data entry

Attention to detail

Customer service understanding

Office software proficiency

Education

High school diploma or AA degree

Bachelor's degree preferred

Job description

Penumbra, Inc. in Alameda, CA is seeking a QA Document Specialist II to support quality processes and regulatory compliance. You will process Engineering Change Orders, verify English usage and Penumbra formatting, and communicate with all levels to maintain document integrity.

The role requires a high school diploma or AA with 2+ years in regulated environments; a Bachelor's degree is preferred. Strong writing, attention to detail, and data-entry skills are essential.