Sr Quality Assurance Engineer

Job Title: Sr Quality Assurance Engineer

Location: Salt Lake City

Schedule: 5 Days onsite

Contract: 6 months to start with potential for extension

Pay Rate: $64/hr

Position Overview

We are seeking a Senior Staff Validation Engineer to support a critical medical device project focused on an access wire within the neurovascular space. This role will provide technical expertise in validation activities, manufacturing processes, design support, and assembly operations.

The ideal candidate will have a strong background in medical device manufacturing, regulatory compliance, and process validation within a highly regulated environment.

Key Responsibilities

• Lead and execute validation activities, including process validations and related documentation.
• Provide technical expertise to support product design, manufacturing, and assembly processes.
• Ensure validation strategies and execution comply with applicable regulatory requirements and quality standards.
• Collaborate cross-functionally with engineering, quality, manufacturing, and project teams to support project milestones.
• Develop, review, and approve validation protocols, reports, and supporting documentation.
• Identify process improvements and implement best practices to enhance manufacturing efficiency and product quality.
• Support risk assessments, change controls, and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in engineering or a related technical discipline.
• Minimum 3 years of relevant experience; 5–8 years preferred.
• Medical device industry experience is required.
• Strong regulatory experience within a regulated medical device environment.
• Hands-on experience with validation activities, including process validation.
• Experience supporting product design and manufacturing assembly processes.
• Extrusion process experience is required.
• Excellent communication, documentation, and cross-functional collaboration skills.
• Ability to work on-site in Salt Lake City, UT, five days per week.

Preferred Qualifications

• Certified Quality Engineer (CQE) certification.
• Certified Quality Auditor (CQA) certification.
• Experience with Val Genesis validation management systems.
• Experience in neurovascular or vascular medical device products.

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