Quality Technician I

QA TechnicianHours: Monday Friday 8:00 AM - 5:00 PM(Career Laddering Opportunities)New employees eligible for:Medical dental and vision benefitsCompany-paid life insurancePaid Time Off (PTO) Accrual11 Paid Holidays in Calendar Year401k Plan with Company MatchMonthly Attendance BonusReferral BonusTuition ReimbursementStatus: Full-TimeReports to: QA ManagerPosition 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 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 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 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 basic quality and technical skills standard inspection methods and established quality processes to perform routine quality control and assurance Manufacturing staff with daily monitoring of product and process quality identifying defects investigating basic quality issues and recommending potential corrective actions under inspections and testing per approved inspection plans quality protocols or test methods recording inspection equipment used and results achieved in appropriate quality records and in the development verification and documentation of simple inspection fixtures gages and visual aids used for manufacturing and quality with Manufacturing and Engineering to develop review and improve inspection criteria acceptance standards and assembly-related quality evaluation and inspection of manufacturing prototypes to verify conformance to drawings specifications and customer with management Manufacturing and Quality teams to investigate quality or process issues and provides input for quality and process improvement quality-related support to production by answering procedural or inspection-related questions when with production teams to improve product quality reduce defects and strengthen adherence to quality standards and work research related to quality requirements for new materials components inspection tools or equipment as Quality Assurance with nonconformance investigations incident reports root cause analyses and corrective and preventive action with and participates in quality-related projects audits preparation and continuous improvement effectively in cross-functional projects and team tasks involving Manufacturing Engineering and opportunities for quality and process improvement and makes recommendations to management based on data observations and inspection standard operating procedures quality tools and documented methods to resolve routine quality problems and escalate complex in and supports training related to quality procedures inspection techniques and compliance quality studies inspections or data collection activities according to provided instructions protocols or inspection duties as assigned or requestedKnowledge 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 Experience:Working knowledge of quality system requirements including ISO 13485 internal quality procedures and documentation proficiency in Microsoft Office applications (Excel Word Outlook); basic working knowledge of Minitab or other statistical tools is a working in a regulated manufacturing environment production facility or cleanroom is a and experience with quality systems software inspection databases CAPA/nonconformance tracking systems or document control systems are a understanding of inspection equipment measurement systems and monitoring tools including proper operation handling and documentation knowledge of manufacturing processes automation or equipment interfaces as they relate to product quality and inspection activities is a 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 -oriented with the ability to exercise sound judgment when identifying documenting and resolving quality-related to develop practical quality-focused solutions to address nonconformances or inspection issues while minimizing cost rework and impact to production to read and comprehend simple product specifications drawings inspection criteria and work to clearly communicate quality issues inspection findings and nonconformance details to appropriate personnel to facilitate corrective a positive attitude toward changes in processes procedures and quality and maintains high standards of quality accuracy and compliance in all work written and verbal communication skills sufficient to clearly document inspection results write reports and read and interpret work-related instructions procedures and to perform basic mathematical functions (addition subtraction multiplication division) using whole numbers fractions and decimals relevant to inspection measurements and data to manage multiple tasks simultaneously while maintaining accuracy and adherence to quality Used:Office Equipment common power and hand tools measurement devices and basic electrical 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 to sit stand and walk for extended periods throughout the workday depending on inspection and production support to use hands and fingers to handle inspect measure and manipulate small components tools inspection devices and documentation materials with a high degree of to frequently bend reach twist and stoop while performing inspections verifying production activities or retrieving materials and to lift carry push or pull materials inspection equipment or sample products weighing up to 25 pounds with or without reasonable to visually inspect products read specifications drawings labels and computer screens including close vision color differentiation and depth to hear and communicate effectively in a manufacturing environment including responding to alarms instructions and discussions related to quality to perform repetitive tasks while maintaining accuracy attention to detail and adherence to quality and documentation standardAbility to work in environments that may include noise temperature variations and exposure to manufacturing materials consistent with medical device production.