Quality Engineer II - Medical Device - LOCAL APPLICANTS PREFERRED

Location: Draper, UT

Pay Rate: $43.00/hr

Duration: 6-Month Contract (May extend or convert to permanent)

Start Date: May 2026

Project Overview

We are seeking a Quality Engineer II to support a major facility expansion. Our team has recently completed construction on a new manufacturing building, and we are now transitioning our production lines—specializing in metal implantable valves—to the new site.

This role is critical for the requalification and validation phase of the move. While the first 4–6 weeks will be primarily desk-based (planning and protocol writing), you will transition to heavy floor-time in July to execute the physical move and validation activities.

Key Responsibilities

• Validation & Qualification: Lead the creation, execution, and review of IQ/OQ/PQ protocols and reports specifically for production line relocation.
• Documentation: Draft technical reports and process confirmation documents to ensure all moved equipment meets medical device regulatory standards.
• Operational Support: Assist the Project Lead with calibration and confirmation of inspection/testing equipment.
• On-Floor Execution: Support the physical movement and setup of portable equipment between buildings as needed.

Required Qualifications

• Experience: 2–4 years of Quality Engineering experience within the Medical Device industry.
• Education: Bachelor’s Degree in Engineering.
• Validation Expert: Proven background in requalification, validation of manufacturing lines, and test method validation.
• Technical Writing: Strong ability to write and execute complex protocols and summary reports.

Preferred Skills

• Automated Equipment: Experience working with or validating automated manufacturing systems is a significant plus.
• Analytical Mindset: Strong problem-solving skills with a high level of attention to detail.
• Communication: Ability to collaborate effectively with project leads and floor staff during a high-stakes transition.