Quality Engineer

Quality Engineer

Location : Hybrid – 4 days / week onsite (domestic travel required)

Rate : $35–43 / hr W-2 (No C2C)

Overview

We are seeking an experienced Quality Engineer to support new product development and sustaining engineering activities for medical devices. This role provides key quality engineering support from concept through commercialization and ongoing maintenance, ensuring compliance with design control processes and global regulatory standards.

Key Responsibilities

Apply quality engineering principles, tools, and methodologies to development and sustaining projects.

Serve as the Quality representative on cross-functional project teams for new product development and product improvements.

Ensure compliance with design control requirements and applicable FDA / ISO quality system regulations.

Review and approve new or modified design and process specifications, including product performance requirements and test methods.

Assist with supplier and internal quality system audits (Auditor-in-Training).

Drive measurable improvements to processes and procedures through structured problem-solving.

Support risk management, change control, process validation, and process capability initiatives.

Education & Experience

Bachelor’s degree in engineering, science, or a related technical discipline.

Minimum 5 years of relevant Quality Engineering experience within the medical device, biotech, or regulated manufacturing industry.

Strong working knowledge of regulatory and quality system standards :

(e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR / IVDR).