Quality Engineer – Design Control

Job Title: Quality Engineer Design Control / Sustaining Quality

Location: Minnesota

Employment Type: Contract W2

Rate: $42 - $46/hr W2

Experience: 2 3+ Years

Industry: Medical Devices

Position Overview:

Seeking a Quality Engineer to support Design Control and Sustaining Engineering activities for medical device products throughout the product lifecycle. This role has a strong focus on design and system aspects, quality systems, documentation, risk management, and sustaining activities within a regulated medical-device environment.

The ideal candidate will have experience with capital equipment and quality systems, along with the ability to work cross-functionally with Design, Manufacturing, Quality, and Regulatory teams.

Key Responsibilities:

• Support Design Control and Sustaining Engineering activities throughout the product lifecycle
• Perform gap assessments of rework, manufacturing, product documentation, and related processes
• Identify compliance risks and recommend appropriate corrective actions
• Review, maintain, and update DHF, DMR, DHR, work instructions, manufacturing procedures, and other controlled documents
• Evaluate proposed product and process changes through risk assessments, impact assessments, and change-control processes
• Support CAPA, change controls, process improvements, and quality deliverables
• Partner with Design, Manufacturing, Quality, and Regulatory teams on cross-functional initiatives
• Support design changes and sustaining activities while maintaining appropriate documentation and traceability
• Identify non-standard rework and process/documentation gaps and support appropriate updates
• Support manufacturing and product documentation updates to maintain compliance with applicable FDA and medical-device quality-system requirements
• Coordinate activities from initiation through execution, documentation, and formal closure
• Apply Design Control, Quality Systems, Risk Management, Change Control, and Sustaining Engineering principles to ongoing product and manufacturing activities

Required / Preferred Qualifications:

• 2 3+ years of relevant Quality Engineering, Design Quality, Sustaining Quality, or Quality Systems experience
• Experience in the medical-device or other regulated industry preferred
• Experience with Design Control and design-related quality activities
• Experience with Quality Systems, change control, risk management, and CAPA
• Familiarity with DHF, DMR, DHR, work instructions, manufacturing procedures, and controlled documentation
• Experience supporting sustaining engineering or product lifecycle activities
• Experience with capital equipment and quality systems is preferred
• Ability to perform gap assessments and identify documentation or compliance risks