Mid-Level Quality Technician

Mid-Level Quality TechnicianWork Location: Durham County, North CarolinaSummary:The Mid-Level Quality Technician is responsible for supporting and improving quality processes, with a focus on manufacturing and supplier management. This role involves maintaining compliance with regulatory standards, supporting audits, and ensuring documentation accuracy.Responsibilities:Develop and update work instructions, standard operating procedures, and forms for various departments.Ensure adherence to quality policies and procedures to maintain product quality standards.Assist with regulatory and customer audits, supporting audit preparation and follow-up activities.Initiate and manage Corrective and Preventive Action (CAPA) and Non-Conformance investigations.Support audits of critical suppliers and help maintain an approved supplier list.Maintain both electronic and physical quality documentation and records.Review manufacturing and maintenance records for compliance and coordinate calibration/testing as needed.Participate in continuous improvement initiatives and assist with quality control issues in manufacturing.Qualifications:Bachelor’s degree or higher, preferably in a science or engineering discipline.Minimum of 3 years of experience in medical device and/or pharmaceutical regulatory or quality roles, ideally in a manufacturing environment.Experience with CAPA and Non-Conformance investigations.Knowledge of regulatory requirements such as ISO 13485:2016 and 21 CFR 210, 211, and 280.Proven ability to write technical documentation, including work instructions and SOPs.Experience with audits and inspections is a plus.Background in maintaining a Quality Management System and document management systems.Strong written and verbal communication skills, with excellent attention to detail.English language proficiency preferred.