Quality Assurance Analyst

Quality Assurance Analyst (Administrative) - Onsite

Location: Acton, MA

Schedule: Monday-Friday, 8:00 AM-5:00 PM (100% Onsite)

Pay: $30/hour

Assignment: Medical leave coverage (3-4 months, potential to extend)

Start: Immediate

We are seeking a highly organized Quality Assurance Analyst to support quality operations in a medical device manufacturing environment in Acton, Massachusetts. This role is very administrative in nature and requires strong attention to detail, documentation control experience, and comfort working on-site five days per week.

Reporting to the Quality Assurance Manager, the QA Analyst will manage weekly, monthly, and quarterly quality metrics across multiple locations. Responsibilities include data collection, analysis, and reporting for operations reviews, Material Review Board (MRB) meetings, and management reviews. The role also supports lot release approvals, stock movements, and adjustments in SAP, making ERP experience essential.

Key Responsibilities:

• Maintain and control quality documentation databases
• Collect, analyze, and present QA metrics (NCMR, Quarantine, IQA, lot qualification, and lot release)
• Support MRB reviews and product release activities
• Perform pre-sterile and post-sterile lot qualification reporting
• Review Device History Records (DHR) and approve or reject lot results
• Execute SAP transactions including stock movements and adjustments
• Maintain complaint and nonconformance records, including corrective actions
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 standards

Minimum Qualifications:

• Bachelor's degree in Engineering or related scientific discipline
• 1+ year of experience in Quality Operations
• Strong data analysis and reporting skills
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint
• ERP experience required (SAP strongly preferred)

Preferred Qualifications:

• Medical device industry experience
• Knowledge of quality systems, documentation control, and configuration data management
• Exceptional clerical, organizational, and communication skills

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

This is an excellent opportunity for a detail-oriented Quality Assurance Analyst ready to start immediately. Click "Apply Now" to begin your administrative QA role.

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