Production Quality Inspector

Production Quality Inspector (4) POSITION OVERVIEW : This position is responsible to ensure that products meet established standards and specifications by identifying defects and ensuring compliance with regulations. This role is vital for maintaining product integrity and customer satisfaction. In alignment with ISO 13854 principles on the interrelation of roles, inspectors report directly to the Production department while maintaining an independent, dotted-line relationship to the Quality department. This structure ensures inspectors are empowered to exercise independence in judgment, reporting, and escalation of quality concerns. RESPONSIBILITIES : Work with the Production department to effectively and efficiently inspect manufactured work products. Exercise independent judgment in inspection activities and escalate quality concerns to Quality Engineers and management when appropriate. Work with Quality Engineers to collect data and drive nonconformance resolution. Drive containment actions as needed when a non-conforming action has been determined, following all Quality Management System (QMS) requirements. QUALIFICATIONS AND SKILLS : Minimum of 3 years’ experience as a quality inspector. 5+ years desired. Prior experience in medical device and / or electromechanical assembly required. Prior experience working with an ERP / MRP system (SAP, InforXA, ExactMax, etc.). Prior experience working in an ISO9001, AS9100, or ISO13485 environment. Prior experience handling / disposition of non-conforming material a plus. Strong attention to detail skills related to product inspection and documentation. Effective communication and ability to communicate cross functionally with all levels. Knowledge of GDP (Good Documentation Practices). Knowledge of visual and mechanical inspection. Knowledge of sampling techniques or equivalent. Ability to interpret inspection procedures, drawings, and instructions. Ability to raise issues to supervision / management for resolution. Ability to work under pressure balancing multiple demands. Ability to use mechanical equipment that may include but not limited to optical comparator, CMM, micrometers, pin gages, etc. Self-starter and independent individual with strong organizational, time management, and computer skills