Hybrid Quality Engineer - Medical Device Design Compliance

REQ Solutions; Maple Grove (MN); Hybrid; USD 67,502 - 81,278; Full time

Job summary

A leading engineering firm is seeking a Quality Engineer for a hybrid role in Maple Grove, MN. This mid-senior level position involves leadership in quality assurance within cross-functional teams, managing design history documentation, and ensuring compliance with regulatory standards. The ideal candidate will have a degree in engineering or a related field and at least 5 years of experience in design quality assurance, particularly in medical device development. Strong communication and collaboration skills are essential.

Qualifications

• 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.
• Experience with ISO 10555, ISO 80369, ISO 7864 is a plus.

Responsibilities

• Act as the voice of quality on the cross-functional product development team.
• Lead the creation, maintenance, and audit-readiness of the Design History File (DHF).
• Execute the risk management process, including Hazard Analyses and DFMEAs.
• Lead planning, execution, and documentation of design verification and validation activities.
• Collaborate with international teams to align quality deliverables.
• Ensure adherence to applicable standards and support regulatory submissions.
• Provide technical leadership and mentorship to global partners.

Skills

Design Quality Assurance

Risk Management

Verification & Validation

Communication

Collaboration

Education

Bachelor's or master's degree in engineering, Mathematics, Physics or related field

Job description

A leading engineering firm is seeking a Quality Engineer for a hybrid role in Maple Grove, MN. This mid-senior level position involves leadership in quality assurance within cross-functional teams, managing design history documentation, and ensuring compliance with regulatory standards. The ideal candidate will have a degree in engineering or a related field and at least 5 years of experience in design quality assurance, particularly in medical device development. Strong communication and collaboration skills are essential.