Senior Quality Assurance Technician
Company: GPAC
Location: Kennewick
Posted on: January 12, 2021
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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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