Sr. Quality Assurance Technician
Company: GT Medical Technologies
Posted on: January 7, 2021
Document Number: TMP-021-01
Document Name: Job Description Template
Page 1 of 3
Sr. Quality Assurance Technician
Full Time Employee - Exempt
The Sr. Quality Assurance Technician will perform inspection and
test activities associated with the acceptance and release of
components, sub-assemblies and finished devices governed by
Standard Operating Procedures and/or Drawings. They will also
perform testing associated to protocols and engineering studies
conducted by cross functional groups and deliver documented
results. This individual will have responsibility for recording
data, notifying key personnel about non-conformances and reporting
findings to Quality, Engineeringand Manufacturing representatives
as necessary. Incrementally, this individual will implement and
maintain traceable and accountable documentation system in
compliance with applicable standards and with company's standard
1. Roles and Responsibilities
--- Review incoming orders to assess compliance to applicable
--- 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
--- Initiates non-conforming material reports and manages their
--- In-process testing of devices (post manufacturing, post
--- 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
--- Ensure the manufacturing facility procedures comply with SOPs
and applicable GMPs and ISO standards and comply with customer
--- 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
--- Manufacturing experience in a radiation-controlled environment
--- Working knowledge of 21CFR Part 820 and ISO 13485:2016
regulations and experience with Quality Management Systems
--- Use various measurement equipment/devices (Caliper, Micrometer,
--- Ability to operate and communicate effectively with
--- 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.
3. Working conditions
--- 10% travel possibility
--- Clean room environment - Safety glasses, gown, hairnet,
face/beard cover, gloves, and hearing protection as required.
Work environment involves exposure to hazardous materials and
situations that require following extensive safety precautions and
the use of protective equipment.
Completes all job duties following HIPAA's guideline for release of
the minimum protected health information necessary and to those
with authority to receive it.
Successfully complete background check as a requirement for working
with potentially sensitive patient information
Medical device manufacturing of medical device requires working
within Class 7 clean room
--- Physical requirements
Regularly walk, sit, and stand
Occasionally bend and push/pull
Confidentiality Statement: This document contains confidential and
proprietary information of GT Medical Technologies and shall not be
reproduced, copied or otherwise disclosed without prior written
permission from GT Medical Technologies. No one shall make use of
this document contrary to the expressed or implied wishes of GT
Keywords: GT Medical Technologies, Richland , Sr. Quality Assurance Technician, Professions , Richland, Washington
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