REQ Solutions ยท 7 hours ago
Quality Engineer (Medical Device)
Maple Grove, MN
Contract
Hybrid
Senior Level
5+ years expREQ Solutions is a company focused on delivering quality in product development, and they are seeking a Quality Engineer to lead and ensure adherence to quality standards in medical device development. The role involves core team leadership, regulatory compliance, and global collaboration to maintain high-quality deliverables.
Outsourcing/Offshoring
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
Qualification
Required
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
Preferred
Experience with ISO 10555, ISO 80369, ISO 7864 is a plus
Company
REQ Solutions
Experience the Power of Strategic Offshore Partnership with REQ Solutions' RPO expertise..
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase