Senior Quality Engineer / Quality Systems Engineer

Position Overview

Step into a role where your work directly supports safer, stronger, more reliable medical products. My client is looking for a Senior Quality Engineer who will play a key role in elevating quality systems, strengthening compliance, and driving meaningful improvements across a growing manufacturing environment. This is your chance to influence products that truly impact lives.

Key Responsibilities

• Lead improvements for CAPA, complaints, nonconformance, audits, training, and validation
• Develop, implement, and enhance processes to meet quality and business metrics
• Analyze defective product trends and drive corrective actions using statistical tools
• Support customer collaborations, supplier qualifications, and change management
• Maintain documentation aligned with ISO 13485 and FDA QSR
• Lead investigations and develop effective CAPAs
• Conduct internal audits and support regulatory and customer audits
• Serve as Quality Lead when needed

Required Qualifications

• Be able to do the job as described.
• Hold a bachelor's degree in engineering or science.
• Bring experience with ISO 13485, FDA 21 CFR 820, and regulated manufacturing.
• Comfortable with statistical process control and process validation.
• ASQ certification or Six Sigma training is a plus.

Benefits & Perks

• Opportunity to shape and improve critical quality systems in a regulated environment
• Meaningful impact supporting medical-grade products and customer programs
• High visibility role collaborating across engineering, operations, and leadership
• Competitive benefits and professional development support