What are the responsibilities and job description for the Quality Engineer (Medical Device) position at REQ Solutions?
Title: Quality Engineer
Location: Maple Grove, MN, 55311
Duration : 12 Months
Type: Hybrid Role
Key Responsibilities:
• 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.
Qualifications:
• 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.
• Proven experience delivering successful new product development product quality deliverables in a regulated environment.
• 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