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
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
