Quality Engineer II

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.

This 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.

Skills and Requirements

• Minimum of 2-5 years of Quality Engineering experience
• Strong technical writing and documentation skills for investigations and approvals
• Hands-on experience on the manufacturing floor with exposure to production processes
• Strong understanding of change management processes, including engineering change orders (ECOs)
• Proficiency with ERP systems (Epicor preferred) for traceability and documentation
• Ability to make data-driven decisions and communicate effectively across teams
• Bachelor's degree in Engineering or a related discipline
• Background in medical device or other regulated industries
• Experience with CAPA, complaint investigations, and process validation
• Familiarity with Lean Six Sigma or other continuous improvement methodologies
• Exposure to PFMEA development and quality planning tools

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to View email address on click.appcast.io.