Quality Engineer (Medical Device)

REQ Solutions; Maple Grove (MN); Hybrid; USD 67.502 - 81.278; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Design Quality Assurance

Risk Management

Verification & Validation

Communication

Collaboration

Ausbildung

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

Jobbeschreibung

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.

Base pay range

$49.00/hr - $59.00/hr

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.
• 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.

iority level

Mid-Senior level

Employment type

Contract

Job function

Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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