Quality Engineer

Duties and Responsibilities

• Lead investigations of quality issues, including internal nonconformities and customer complaints. Manage Corrective and Preventative Action (CAPA) activities, including root cause analysis, solution identification, implementation, and effectiveness verification.
• Own the CAPA process and identify opportunities to improve its effectiveness, efficiency, and cross-functional coordination.
• Analyze quality data, communicate trends to cross-functional teams, and identify opportunities for product and process improvement.
• Develop and implement effective measurement and inspection methods. Establish systems for data collection, management, and monitoring to support data-driven decision-making and problem-solving.
• Support new product development activities by defining inspection processes and providing training to ensure product quality, performance, and regulatory compliance requirements are met.
• Collaborate with engineering and production teams to establish appropriate sampling plans for evaluating product and process quality.
• Participate in internal and external audits; determine appropriate corrective and preventative actions to address audit findings
• Support process verification and validation activities, including the development and execution of IQ, OQ, and PQ protocols and reports.
• Provide technical guidance to engineers, technicians, and cross-functional teams on quality principles, best practices, and problem-solving methodologies.
• Perform additional responsibilities as requested to achieve business objectives

Qualifications

• BS degree in Engineering, Quality, or a related field, with 3-5 years of experience
• Experience with medical devices or other highly regulated industries/products desired
• Demonstrated ability to work and make decisions independently and lead others to the completion of assigned tasks
• Demonstrated ability to communicate effectively both verbally and in written form

Physical Requirements:

• Must be able to sit, stand, and/or walk for up to 8-10 hours per day
• Must be able to occasionally lift up to 25 pounds
• May require occasional early morning or late evening teleconferences
• May require occasional visits to suppliers