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