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Medical Device - Quality Engineer (Part-Time)

Cambridge, MA 02139

Posted: 03/17/2026 Employment Type: Contract Industry: Engineering Job Number: 44301 Pay Rate: 65.00

Job Description

Our client is seeking a highly detail-oriented and adaptable Quality Engineer to lead and execute quality initiatives across product development, manufacturing, and supplier operations. This role serves as the primary on-site quality representative, working closely with senior leadership to ensure consistent execution, strong compliance, and high product standards.

Responsibilities:
  • Develop, qualify, and maintain test methods and associated tooling
  • Execute verification and validation activities, including protocol/report generation
  • Perform statistical analyses (e.g., Gage R&R, DOE) using tools such as Minitab
  • Perform incoming inspections (including AQL), labeling, and packaging checks
  • Support supplier selection, qualification, and ongoing quality management
  • Collaborate with internal teams and external partners to ensure robust manufacturing and inspection processes
  • Contribute to design history documentation, including risk management and verification activities
  • Conduct in-process and final inspections, including record review
  • Support investigations, root cause analysis, and corrective/preventive actions
  • Participate in sterilization-related reviews as needed
  • Maintain document control, traceability, and quality records
  • Support and enhance the Quality Management System (QMS)
  • Ensure compliance with applicable regulations and standards (e.g., ISO 13485, FDA requirements)
  • Partner with engineering and operations teams to integrate quality throughout development
  • Support design controls, design transfer, and product release readiness
  • Identify risks and proactively drive continuous improvement initiatives
Requirements:
  • Bachelor’s degree in engineering
  • 5+ years of hands-on experience in the medical device industry (Class II or III preferred)
  • Experience with quality systems, design controls, and supplier quality management
  • Strong skills in test method development, risk management, and root cause analysis (e.g., FMEA, 5 Whys)
  • Proficiency with statistical analysis tools (e.g., Minitab or equivalent)
  • Familiarity with ISO 13485, ISO 14971, and FDA quality system regulations
  • High level of attention to detail and documentation rigor
  • Ability to work independently in a fast-paced environment
Preferred:
  • Combined R&D and quality engineering experience
  • Experience with complex or implantable medical devices
  • Familiarity with sterilization processes and validation
  • Experience in minimally invasive or precision device manufacturing

Pay $46 - $65 / hour W2 Depending on experience

#ZREng
 

Meet Your Recruiter

John Sabbagh
Recruiting Manager

John Sabbagh has over 10 years of recruiting experience. Starting his career as an Entry Level Recruiter at Panther, our candidates find him genuine and great resource to their career search!

Fun Fact: John is a sports fanatic, he plays in horseshoe and cornhole leagues and loves fantasy football.

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