Quality Monitoring & Improvement Specialist I (Medical Devices)

TL;DR

Quality Monitoring & Improvement Specialist I (MedTech): Supporting Quality Management System (QMS) processes, specifically CAPAs, NCRs, and Deviation Authorizations with an accent on regulatory requirements and documentation review. Focus on coordinating board meetings, compiling trending data, and ensuring compliance with safety standards.

Location: Onsite in Alameda, CA

Salary: $33.00 – 45.00 per hour

Company

Global healthcare company focused on innovative therapies and novel products for challenging medical conditions.

What you will do

• Manage QMS process documentation, including Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs), and Deviation Authorizations (DAs).
• Organize and facilitate board meetings to review documentation and provide regular status updates.
• Collaborate cross-functionally with Manufacturing Engineering, Quality Engineering, Regulatory Affairs, and R&D teams.
• Compile data for monthly trending meetings and create analysis charts and graphs using Excel.
• Support internal and external audits and maintain strict control and access of quality records.

Requirements

• Bachelor's degree in engineering, life sciences, or a related field.
• 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment.
• Proficiency with MS Word, Excel, and PowerPoint.
• Ability to create basic charts and graphs for data analysis.
• Strong oral, written, and interpersonal communication skills with high attention to detail.

Nice to have

• Bilingual fluency in Spanish and English.
• Experience in biotech or other highly regulated industries.

Culture & Benefits

• Collaborative teamwork environment with a focus on continuous learning.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) with employer match.
• Paid parental leave and accrued vacation/sick time.
• Eleven paid company holidays per year.