Quality Technician II

Quality Technician II Mebane, NC
Job Type
Full-time
Description Company Overview Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products. At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members. Job Summary The Quality Technician II responsible for supporting the site's quality activities under close supervision. This position focuses on learning company procedures, gaining familiarity with inspection tools, and performing routine quality tasks to help ensure products meet customer requirements. The technician follows detailed instructions and works as part of a team to support the effectiveness of the quality management system. Job Responsibilities Ability to work independently with minimal supervision Solid understanding of assigned processes, areas, and products Strong communication skills (written and verbal) Critical thinking and problem-solving ability Understanding of Quality Plans (QPs) Document Control & QMS Serve as the primary gatekeeper for controlled documents and quality records within the QMS
Manage and maintain all controlled documents within the ERP system
Create, update, and control procedures, work instructions, and forms
Establish and maintain document hierarchy and control processes
Ensure proper document identification, classification, and filing
Perform document reviews to ensure accuracy, completeness, and traceability
Maintain revision control and ensure availability of current documents at point of use
Control obsolete documents to prevent unintended use
Log and track document changes within the QMS dashboard
Distribute documents and ensure acknowledgment by relevant personnel Audit & Compliance Support Support internal, customer, regulatory, and registrar audits
Ensure compliance with company procedures, GMP, GDP, and regulatory requirements
Maintain document traceability and inspection readiness
Calibration System Co responsible for the calibration system, including asset tracking and scheduling
Monitor calibration due dates and perform internal calibrations as required
Coordinate with external suppliers for calibration services Quality Operations Support Review Nonconformance Reports (MRB) daily and support inventory management activities
Process and approve deviations as required
Maintain ERP system records for MRB and deviations tracking
Collect and analyze data related to quality issues
Support production by addressing quality-related questions and concerns
Perform AQL activities as required
Requirements
High school diploma or equivalent required
2 years of experience in a quality, manufacturing, or technical environment preferred.
Willingness to learn visual inspection techniques using microscopes.
Exposure to or interest in using precision measurement tools such as comparators, height gauges, or video systems.
Basic understanding or willingness to learn Geometric Dimensioning and Tolerancing (GD&T).
Strong attention to detail and ability to follow instructions carefully.
Willingness to learn documentation processes and procedures.
Basic math and problem-solving skills.
Good communication skills and ability to work in a team environment.
Openness to training and feedback.
Awareness of safety practices and commitment to safe work behavior.