Quality Engineer

Insight Global is seeking a Quality Engineer for one of our clients in the medical device/manufacturing industry. This individual will support new product development, process validation, risk management, quality investigations, and continuous improvement initiatives. The ideal candidate has experience in regulated environments and can effectively partner with cross-functional teams to ensure product quality, compliance, and risk mitigation throughout the product lifecycle.

Responsibilities

• Support new product development activities, including risk assessments, design controls, and specification reviews.
• Develop and maintain risk management documentation, including DFMEA and PFMEA analyses.
• Create and execute process validation protocols, reports, and associated quality documentation.
• Lead root cause investigations using tools such as 5 Whys, Fishbone Diagrams, and corrective action methodologies.
• Investigate nonconforming materials, customer complaints, and quality events to identify and implement corrective actions.
• Support change control processes and ensure compliance with quality management system requirements.
• Utilize statistical methods and quality engineering tools to analyze process and product performance.
• Partner with Engineering, Operations, R&D, and Manufacturing teams to drive quality improvements.
• Support internal and external audits, inspections, and regulatory compliance activities.
• Perform additional duties as assigned.

Qualifications

• 3+ years of quality engineering experience within a medical device, pharmaceutical, or other regulated manufacturing environment.
• Experience with process validation, risk management, CAPA, root cause analysis, and quality investigations.
• Knowledge of FDA, ISO, GMP, and other applicable quality standards and regulations.
• Experience with statistical analysis tools and methodologies.
• Familiarity with Lean Manufacturing, 5S, and/or Six Sigma principles.
• Strong project management, communication, and cross-functional collaboration skills.
• Proficiency with Microsoft Office and quality/statistical software such as Minitab.
• Ability to manage multiple priorities in a fast-paced environment.