Quality Engineer

Overview

The Scientific Team at Pride Health is assisting a top diagnostic laboratory near Marlborough, MA to identify the right person to fill a contract Hybrid
Quality Engineer opening.

• Lead and maintain quality systems compliant with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
• Drive design control and risk management activities across the IVD product life cycle
• Review and approve design inputs/outputs, V&V documentation, and risk management files
• Lead internal and external audits, CAPA, nonconformance investigations, and supplier qualification
• Support regulatory submissions, complaints handling, and post-market surveillance activities
• Collaborate cross-functionally to embed quality and regulatory requirements into product development
• Analyze quality metrics and drive continuous improvement initiatives

• Bachelor’s degree required
• 8+ year experience in medical device/IVD
• Strong design control and risk management expertise
• Deep knowledge of FDA, ISO, and IVDR requirements
• ASQ and/or RAC certification preferred

• Schedule:
  
  Monday-Friday 8am-5pm (hybrid - 3-4 days onsite)
• Job Type: 1 year contract to potential hire/extension
• Pay rate range: $60-65/hr

Must be authorized to work in the United States.

Pride Health offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

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