Quality Technician

GT Medical Technologies, Inc.•Richland, WA

44m

About The Position

The Quality Assurance Technician I is responsible for verifying the accuracy, completeness, and compliance with specifications of Reviews Device History Record (DHR) data entries per applicable departmental procedure(s) for review of quality records. Records and escalates exceptions to DHR in the applicable quality management systems. Maintains DHR records and generates nonconformance records when necessary to alert the team of any issues Supports manufacturing of both product lines through the following: Review incoming orders to assess compliance to applicable standards. Perform final product inspections and responsible for documenting product release activities. Summarizes data and coordinates with manufacturing supervisors the efficient/timely release of product Follows detailed procedures documented in SOP's, work instructions, forms and on check lists. In-process testing of devices (post manufacturing, post sterilization, etc.). Manages forms/manufacturing facility procedures in 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/documentation ensuring these are easily retrievable. Ensure consistency/compliance of document structure and compliance with established SOPs, ISO standards and applicable cGMP. Adheres to the Company’s purpose operating principles, building a positive and productive team culture. Comply with Company policies and procedures and safety protocol. Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions. Training employees on the job duties associated with the Quality Assurance Technician I job role. Other duties as assigned.

Requirements

Associate’s degree in technical or business related field / Bachelor’s degree preferred.
1 year of experience in a radiation-controlled environment preferred.
Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and experience with Quality Management Systems preferred.
Ability to use various measurement equipment/devices (Caliper, Micrometer, Scale, Comparator).
Strong documentation and organizational skills.
Ability to operate and communicate effectively with cross-functional teams.
Strong analytical and problem-solving skills.
Ability to multi-task and work within deadlines.
Must be detail oriented with the ability to work both independently and as a part of a dynamic team.
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 and environmental monitoring testing is preferred.
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.
Excellent written and verbal communication skills.
Proficient in using Microsoft office programs (Word, Excel, and PowerPoint).
Willingness to work a flexible schedule.
Able to travel for work as needed.
Satisfactorily pass comprehensive background screening.

Nice To Haves

Associate’s degree in technical or business related field / Bachelor’s degree preferred.
1 year of experience in a radiation-controlled environment preferred.
Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and experience with Quality Management Systems preferred.
Prior experience in clean room operations and environmental monitoring testing is preferred.

Responsibilities

Review incoming orders to assess compliance to applicable standards.
Perform final product inspections and responsible for documenting product release activities.
Summarizes data and coordinates with manufacturing supervisors the efficient/timely release of product
Follows detailed procedures documented in SOP's, work instructions, forms and on check lists.
In-process testing of devices (post manufacturing, post sterilization, etc.).
Manages forms/manufacturing facility procedures in 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/documentation ensuring these are easily retrievable.
Ensure consistency/compliance of document structure and compliance with established SOPs, ISO standards and applicable cGMP.
Adheres to the Company’s purpose operating principles, building a positive and productive team culture.
Comply with Company policies and procedures and safety protocol.
Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
Training employees on the job duties associated with the Quality Assurance Technician I job role.
Other duties as assigned.