Quality Assurance - Quality Technician I

Hours: Monday – Friday 8:00 AM - 5:00 PM Medical, dental, and vision benefits Company-paid life insurance Paid Time Off (PTO) Accrual 11 Paid Holidays in Calendar Year 401k Plan with Company Match Monthly Attendance Bonus Referral Bonus Tuition Reimbursement Status: Full-Time Reports to: QA Manager Position Description: This position is responsible for supporting quality system activities to ensure compliance with ISO 13485, company procedures, and customer requirements. Performs inspections, testing, and documentation reviews to verify product and process conformance. Assists in activities related to quality control, nonconforming material, corrective and preventive actions, and continuous improvement initiatives. Exhibits working knowledge of quality operations within the assigned work area. Projects a positive example for others to follow in the workplace. Solves problems of moderate scope and complexity. Demonstrates Viant Values. Position Authority: Under close supervision, performs entry-level quality duties as assigned to support inspection, testing, documentation, and monitoring of products and processes used in medical device manufacturing. Supports quality system activities including incoming, in-process, and final inspections; documentation review; nonconforming material activities; and compliance with ISO 13485 and internal quality procedures. Performs related quality duties as assigned. Makes recommendations and reviews with supervisor OR team members in semi-structured assignments to develop solutions to a variety of problems of moderate scope and complexity. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Reviews progress and evaluate results. Essential Job Functions: Generates, reviews, and updates quality documentation such as inspection procedures, work instructions, quality forms, data collection sheets, nonconformance records, and quality-related work orders, as assigned. Applies basic quality and technical skills, standard inspection methods, and established quality processes to perform routine quality control and assurance activities. Assists Manufacturing staff with daily monitoring of product and process quality, identifying defects, investigating basic quality issues, and recommending potential corrective actions under supervision. Performs inspections and testing per approved inspection plans, quality protocols, or test methods, recording inspection equipment used and results achieved in appropriate quality records and reports. Assists in the development, verification, and documentation of simple inspection fixtures, gages, and visual aids used for manufacturing and quality inspections. Collaborates with Manufacturing and Engineering to develop, review, and improve inspection criteria, acceptance standards, and assembly-related quality instructions. Supports evaluation and inspection of manufacturing prototypes to verify conformance to drawings, specifications, and customer requirements. Collaborates with management, Manufacturing, and Quality teams to investigate quality or process issues and provides input for quality and process improvement initiatives. Provides quality-related support to production by answering procedural or inspection-related questions when needed. Interfaces with production teams to improve product quality, reduce defects, and strengthen adherence to quality standards and work instructions. Performs research related to quality requirements for new materials, components, inspection tools, or equipment, as assigned. Assists Quality Assurance with nonconformance investigations, incident reports, root cause analyses, and corrective and preventive action activities. Assists with and participates in quality-related projects, audits preparation, and continuous improvement initiatives. Participates effectively in cross-functional projects and team tasks involving Manufacturing, Engineering, and Quality. Identifies opportunities for quality and process improvement and makes recommendations to management based on data, observations, and inspection results. Uses standard operating procedures, quality tools, and documented methods to resolve routine quality problems and elevate complex issues. Participates in and supports training related to quality procedures, inspection techniques, and compliance requirements. Executes quality studies, inspections, or data collection activities according to provided instructions, protocols, or inspection plans. Other duties as assigned or requested Knowledge and Education: High school diploma or equivalent required. A 2 year associate degree in quality, engineering technology, manufacturing, or a related technical field is preferred. One (1) to three (3) years of experience in a quality, manufacturing, inspection, or regulated production environment preferred. Job Experience: Working knowledge of quality system requirements, including ISO 13485, internal quality procedures, and documentation controls. Advanced proficiency in Microsoft Office applications (Excel, Word, Outlook); basic working knowledge of Minitab or other statistical tools is a plus. Experience working in a regulated manufacturing environment, production facility, or cleanroom is a plus. Knowledge and experience with quality systems software, inspection databases, CAPA/nonconformance tracking systems, or document control systems are a plus. Basic understanding of inspection equipment, measurement systems, and monitoring tools, including proper operation, handling, and documentation requirements. Basic knowledge of manufacturing processes, automation, or equipment interfaces as they relate to product quality and inspection activities is a plus. Skills and Competencies: Ability to properly use standard inspection tools, measurement devices, gauges, test equipment, and basic hand tools to support inspection, testing, and troubleshooting of product and process quality issues. Detail-oriented with the ability to exercise sound judgment when identifying, documenting, and resolving quality-related problems. Ability to develop practical quality-focused solutions to address nonconformances or inspection issues while minimizing cost, rework, and impact to production schedules. Ability to read and comprehend simple product specifications, drawings, inspection criteria, and work instructions. Ability to clearly communicate quality issues, inspection findings, and nonconformance details to appropriate personnel to facilitate corrective action. Maintains a positive attitude toward changes in processes, procedures, and quality requirements. Demonstrates and maintains high standards of quality, accuracy, and compliance in all work performed. Possesses written and verbal communication skills sufficient to clearly document inspection results, write reports, and read and interpret work-related instructions, procedures, and policies. Ability to perform basic mathematical functions (addition, subtraction, multiplication, division) using whole numbers, fractions, and decimals relevant to inspection measurements and data collection. Ability to manage multiple tasks simultaneously while maintaining accuracy and adherence to quality standards. Equipment Used: Office Equipment, common power and hand tools, measurement devices and basic electrical devices. Physical Requirements: Ability to perform work in a manufacturing and/or cleanroom environment while wearing required personal protective equipment (PPE), including gowns, gloves, masks, and safety glasses. Ability to sit, stand, and walk for extended periods throughout the workday, depending on inspection and production support needs. Ability to use hands and fingers to handle, inspect, measure, and manipulate small components, tools, inspection devices, and documentation materials with a high degree of dexterity. Ability to frequently bend, reach, twist, and stoop while performing inspections, verifying production activities, or retrieving materials and tools. Ability to lift, carry, push, or pull materials, inspection equipment, or sample products weighing up to 25 pounds, with or without reasonable accommodation. Ability to visually inspect products, read specifications, drawings, labels, and computer screens, including close vision, color differentiation, and depth perception. Ability to hear and communicate effectively in a manufacturing environment, including responding to alarms, instructions, and discussions related to quality issues. Ability to perform repetitive tasks while maintaining accuracy, attention to detail, and adherence to quality and documentation standard Ability to work in environments that may include noise, temperature variations, and exposure to manufacturing materials consistent with medical device production. #J-18808-Ljbffr Viant Medical Inc.