REQ Solutions
Responsibilities
Act as the voice of quality on the cross‑functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards.
Lead the creation, maintenance, and audit‑readiness of the Design History File (DHF), ensuring all documentation meets internal and regulatory requirements.
Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable.
Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution.
Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies.
Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed.
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.
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.
Seniority level Mid‑Senior level
Employment type Contract
Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing
Location Maple Grove, MN
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Act as the voice of quality on the cross‑functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards.
Lead the creation, maintenance, and audit‑readiness of the Design History File (DHF), ensuring all documentation meets internal and regulatory requirements.
Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable.
Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution.
Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies.
Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed.
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.
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.
Seniority level Mid‑Senior level
Employment type Contract
Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing
Location Maple Grove, MN
#J-18808-Ljbffr