Design Quality Engineer

Newton, MA, US • Posted 30+ days ago • Updated 7 hours ago
Contract Independent
On-site
USD $60.00 - 70.00 per hour
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Fitment

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Job Details

Skills

  • Mergers and Acquisitions
  • System Requirements
  • Quality Improvement
  • Product Development
  • Risk Management
  • Verification And Validation
  • Regulatory Compliance
  • Testing
  • Usability
  • Evaluation
  • Manufacturing
  • DMR
  • Inspection
  • Documentation
  • Performance Metrics
  • Root Cause Analysis
  • Biomedical Engineering
  • Life Sciences
  • Medical Devices
  • FOCUS
  • ISO 13485
  • ISO 9000
  • Statistics
  • Minitab
  • Corrective And Preventive Action
  • Management
  • Communication
  • Privacy
  • Marketing

Summary

Location: Newton, MA
Salary: $60.00 USD Hourly - $70.00 USD Hourly
Description: Our client is currently seeking a Design Quality Engineer

Job Title: Design Quality Engineer
Location: Auburndale, MA 02466
Duration: 1 Year Contract

Position Overview We are seeking a Senior Design Quality Engineer (Consumables) to support the development and sustaining of sterile, single-use medical devices. This role will act as a quality subject matter expert, ensuring compliance with applicable standards and quality system requirements. Responsibilities include risk management, verification and validation, supplier qualification, manufacturing transfer, and ongoing quality improvement activities.

Responsibilities

New Product Development
  • Provide quality expertise for sterile, single-use medical devices, including packaging, sterilization, and biocompatibility.
  • Support risk management activities per ISO 14971 and maintain the Risk Management File.
  • Develop and review FMEAs (Use, Design, Process) to identify and mitigate risks.
  • Support design verification and validation activities, including compliance testing (ISO 10993, IEC 60601-1, packaging/sterilization).
  • Maintain the Usability Engineering File per IEC 62366.
  • Support supplier qualification, process validation, and equipment evaluation.
  • Assist with manufacturing transfer activities, including DMR/DHR documentation and validation protocols.
  • Develop and maintain work instructions, procedures, and inspection documentation.

Sustaining Activities
  • Collect and analyze quality and performance metrics to drive improvements.
  • Lead or support CAPAs to resolve systemic issues.
  • Participate in product complaint investigations and root cause analysis.
  • Support disposition of nonconforming material and other quality-related activities.


Qualifications
  • Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
  • 5-7 years of experience as a Quality Engineer in the medical device industry, with focus on sterile, single-use consumables and packaging.
  • Hands-on experience with ISO 10993-1, ISO 11607-1, and ISO 11135 preferred.
  • Working knowledge of QMSR, ISO 13485, ISO 14971, IEC 62366, and MDR requirements.
  • Experience with applied statistics (Minitab or equivalent).
  • Strong background in CAPA, nonconformance management, and complaint investigations.
  • Experience supporting De Novo and/or PMA submissions preferred.
  • Excellent verbal and written communication skills.

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: cxjudgpa
  • Position Id: 1119532
  • Posted 30+ days ago

Company Info

About Judge Group, Inc.

The Judge Group, is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better.

Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India. The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications.

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