Quality Manager

Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, sexual orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together. IntePros is currently looking for a Quality Manager to join one of our growing medical device clients in Kearney, NE. JOB SUMMARY In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset. Essential Duties and Responsibilities • Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary. • Direct reports include quality control supervisors. • Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude. • Maintains and instills in others a "quality at the source" mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production. • Maintains and instills in others an "immediate audit readiness" mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability. • Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations. • Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product. • Identifies and develops opportunities to improve existing processes and procedures • Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience. • Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. • Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. • Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required. • Manages the development of documentation and procedures during the qualification of new equipment/inspection methods. • Exhibits regular, reliable, punctual and predictable attendance. • Creates, prepares, implements and improves Quality Control KPIs metrics. • Determines/sets Goals & Objectives for the Quality control organization and training programs for team's development purposes. • Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed. • Ensures equipment is up to date on Preventive maintenance and calibration activities. • Maintains the lab/area well organized with a 5S mindset. • Other duties as assigned. #LI-KS1

Created: 2024-11-05