Quality Engineer; Medical Device

This range is provided by REQ Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$49.00/hr - $59.00/hr

Title:

Quality Engineer

Location:

Maple Grove, MN, 55311

Duration: 12+ Months

Type:
Hybrid Role

• Core Team Leadership:
  Act as the voice of quality on the cross-functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards.
• Design History File (DHF) Ownership:
  Lead the creation, maintenance, and audit-readiness of the DHF, ensuring all documentation meets internal and regulatory requirements.
• Risk Management:
  
  Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable.
• Verification & Validation (V&V):
  Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution.
• Global
  
  Collaboration:
  
  Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies.
• Regulatory Compliance:
  Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed.
• Mentorship & Guidance:
  Provide technical leadership and mentorship to global, cross-functional partners.

• Bachelor’s or master’s degree in engineering, Mathematics, Physics or related field.
• Minimum 5 years of experience in Design Quality Assurance or Product Development Engineering, preferably in medical device development.
• Strong knowledge of Design Controls, Risk Management, and Verification & Validation methodologies.
• Excellent communication and collaboration skills across global teams.
• Experience with ISO 10555, ISO 80369, ISO 7864 is a plus.

Mid-Senior level

Contract

Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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