Quality Engineer II

Required Skills & Experience
- Minimum of 2-5 years of Quality Engineering experience\n- Strong technical writing and documentation skills for investigations and approvals\n- Hands-on experience on the manufacturing floor with exposure to production processes\n- Strong understanding of change management processes, including engineering change orders (ECOs)\n- Proficiency with ERP systems (Epicor preferred) for traceability and documentation\n- Ability to make data-driven decisions and communicate effectively across teams\n- Bachelor’s degree in Engineering or a related discipline

Nice to Have Skills & Experience
- Background in medical device or other regulated industries\n- Experience with CAPA, complaint investigations, and process validation\n- Familiarity with Lean Six Sigma or other continuous improvement methodologies\n- Exposure to PFMEA development and quality planning tools

Job Description

Insight Global is partnering with a leading medical device design and manufacturing organization to hire a Quality Engineer. This individual will support the production of advanced electronic and software-driven medical devices. In this role, you will ensure the integrity of quality systems, drive process improvements, and maintain strong relationships with internal stakeholders. You will play a key part in supporting New Product Introduction (NPI), helping transition products from design into full-scale manufacturing while embedding quality into every stage of the process.\n\nThis position is ideal for someone who has the ability to thrive in a fast-paced, evolving environment, uses risk-based thinking, and is passionate about continuous improvement. The position offers a balanced mix of documentation, process improvement, and hands-on engagement with manufacturing operations. You’ll work closely with engineering and operations teams to ensure compliance, streamline processes, and deliver high-quality products to market. It is a high-impact opportunity within a collaborative team, offering long-term growth and career development.