Sr. Quality Assurance Technician

Company: GT Medical Technologies
Location: Richland
Posted on: January 7, 2021

Job Description:

Document Number: TMP-021-01

Document Name: Job Description Template

Effective Date:

Revision:

Page 1 of 3








Position Title:

Sr. Quality Assurance Technician



Date:

6/1/2020

Department:

Operations



Job Status:

Full Time Employee - Exempt

Location:

Richland, WA



Travel Required:

10%

Reports to:

TBD



Direct Reports:

N/A

Education Required:

Associates Degree



Experience Required:

5plus years

Overview

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 operating procedures.

1. Roles and Responsibilities



--- 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 SOP

--- Initiates 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.

2. Qualifications



--- 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 Systems

--- Use 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.



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 Medical Technologies.

Keywords: GT Medical Technologies, Richland , Sr. Quality Assurance Technician, Professions , Richland, Washington