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