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Development Quality Engineer

Salary undisclosed

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Job Title: Development Quality Engineer

Location: St. Paul, MN Onsite

Duration: 12-Month Contract

Job Description:

We are seeking a Development Quality Engineer II with 2-5 years of experience to support quality disciplines, design control deliverables, and risk management activities within the medical device industry. The role requires strong problem-solving skills, cross-functional collaboration, and expertise in quality systems compliance.

Key Responsibilities:

  • Lead and support design control deliverables for product development and design change projects.
  • Ensure on-time execution of Quality Plans for internal Product Development Process (PDP) and OEM-based Clinical Product Development (CPDP).
  • Develop and execute design verification test plans and reports for product/system requirements.
  • Lead and support Risk Management activities, including hazard analysis, FMECA, and cybersecurity risk assessments.
  • Identify Essential Outputs and generate related reports.
  • Oversee completion of labeling verification activities and reports.
  • Collaborate with design engineering on product requirements, verification, and validation.
  • Ensure Design History File (DHF) integrity, content completion, and regulatory compliance.
  • Perform timely and objective document change request reviews.
  • Implement process control systems to support development, qualification, and manufacturing.
  • Assist with CAPA systems, assurance processes, and business system improvements.
  • Apply systematic problem-solving methodologies to resolve quality issues.
  • Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.

Qualifications:

  • Bachelor’s degree in Engineering or a related technical field.
  • 2-5 years of experience in quality engineering, product development, or regulatory compliance.
  • Strong skills in verbal and written communication, teamwork, multitasking, and organization.
  • Proficiency in risk management, design verification, and regulatory standards.
  • Advanced computer skills and experience with quality systems in a regulated environment.