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Senior Quality Assurance Technician

Company: GPAC
Location: Kennewick
Posted on: January 12, 2021

Job Description:

Review incoming orders to assess compliance to applicable standards. Perform final product inspections and responsible for documenting product release activities.Performs incoming inspection for raw materials in accordance with applicable specifications, drawings, work instructions and SOPInitiates non-conforming material reports and manages their closure.In-process testing of devices (post manufacturing, post sterilization, etc.).Functional and/or dimensional testing of engineering studies and validation protocols.Complete special projects as assigned by direct supervisor.Ensure there are periodic reviews of all documents to maintain consistency to customer requirements, SOPs and changes or improvements to processes.Maintain a system to create, update, and control forms and manufacturing facility procedures ensuring compliance with organizational guidelines.Ensure the manufacturing facility procedures comply with SOPs and applicable GMPs and ISO standards and comply with customer requirements.Maintain files for documentation related to validations and qualifications ensuring these are easily retrievable.Ensure consistency of document structure and compliance to established SOPs, ISO standards and applicable cGMP.Manage the schedule and coordination of calibration systems across all manufacturing facility equipment.Review all documents for accuracy and completeness.Other duties as assigned.Adhere to all company policies.Follow all safety rules and safety procedures.Associate's degree in technical or business related field / Bachelor's degree preferred.5 years manufacturing/operations experience including a minimum of 2 years medical device manufacturing. Startup experience preferred.Manufacturing experience in a radiation-controlled environment preferred.Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and experience with Quality Management SystemsUse various measurement equipment/devices (Caliper, Micrometer, Scale, Comparator).Ability to operate and communicate effectively with cross-functional teams.Strong MS Excel, MS Word, and Outlook experience.Strong analytical and problem-solving skills.Ability to multi-task and work within deadlines.Excellent communication and organizational skills.Ability to establish and maintain effective working relationships relevant with cross functional teams.Ability to read and interpret Standard Operating Procedures (SOPs) and work instructions.Prior QA experience required. Ability to read, write and follow verbal and written instructions.Prior experience in clean room operations. Experience with environmental monitoring testing a plus.Ability to accurately collect and organize data.Must be able to perform basic mathematical functions using whole numbers, fractions and decimals.Must be able to compute averages, rates, percent and to draw and interpret bar graphs.All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 30 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Keywords: GPAC, Kennewick , Senior Quality Assurance Technician, Professions , Kennewick, Washington

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