Associate Quality Engineer

Company Industry: Medical Device Manufacturing

Title: Associate Quality Engineer

Pay Range: $30-40/hr

This role is responsible for supporting base business operations and smaller-scale projects while driving process changes and continuous improvement initiatives. The position focuses on reducing scrap, optimizing manufacturing efficiency, and managing non-conformance investigations by implementing effective corrective actions. It also involves supporting quality systems such as CAPA and deviation management, assisting with equipment onboarding—including clean lines, packaging and sealing equipment, lasers, CNC machines, and robotics—and collaborating cross-functionally in a dynamic, fast-paced environment to ensure operational excellence.

• 1–2 years of process engineering experience within a GMP-regulated manufacturing environment
• Proven ownership of CAPAs and deviation investigations, from drafting through approval Hands-on experience with process changes, continuous improvement, and scrap reduction activities
• Demonstrated autonomous decision-making and ability to lead procedures
• Excellent soft skills to navigate cross-functional and high-pressure settings Strong communication and interpersonal skills.

• Experience owning and executing IQ, OQ, and PQ validation protocols
• Exposure to large utility systems (e.g., water systems) from a validation perspective
• Experience with injection molding and/or CNC equipment
• Background in pharma or med device industries with emphasis on quality and validation
• Scrap validation
• Quality NRs
• General Process Engineer
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Knowledge of statistical data analysis tools (e.g. Minitab)
• Knowledge of Process Excellence/Six Sigma tools and methodologies
• Windchill, ETQ, MES