Quality Engineer

Role: Quality Engineer

Location: Westford, MA
Duration: 12 Months
Shift: 8:00 AM 5:00 PM

Job Summary

We are seeking a Quality Engineer to support quality assurance activities within a medical device manufacturing environment. The role focuses on ensuring compliance with regulatory standards and supporting post-market quality initiatives.

Key Responsibilities

• Initiate and execute quality assurance activities aligned with FDA Quality System Regulations and ISO 13485
• Develop and maintain incoming inspection processes and documentation
• Provide in-process QA support, including inspection and document review
• Perform final product acceptance activities
• Manage sterilization processes, validations, and sterile loads
• Track and manage nonconforming materials; lead MRB (Material Review Board) activities
• Act as the QA lead with suppliers, contractors, and consultants
• Lead complaint investigations and failure analysis for returned products
• Drive CAPA (Corrective and Preventive Actions) and quality improvement initiatives
• Support internal quality systems (receiving inspection, calibration, etc.)
• Assist with internal audits and management review meetings
• Establish and monitor quality metrics

Project Scope

• Work on high-impact sustaining quality projects
• Support post-market product updates
• Maintain risk documentation and MPIs
• Conduct design change evaluations
• Perform complaint investigations and analysis

Required Qualifications

• 2 3 years of Quality Engineering experience
• Experience in medical devices (preferred) OR pharma/electronics
• Background in a highly regulated industry
• Hands-on experience with:
  • Risk assessment & review
  • CAPA processes
  • Inspection plan development
  • Documentation change management
  • Problem-solving methodologies (DMAIC)
  • Project and time management