Quality Assurance Specialist at GT Medical Technologies, Inc.

Richland, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

35.0

Posted On

18 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Product Inspection, Device History Record Review, Nonconformance Reporting, Environmental Monitoring, ISO 13485, 21CFR Part 820, Clean Room Operations, Measurement Equipment, Documentation, Analytical Skills, Problem Solving, GMP Compliance, Microsoft Office, Validation Protocols

Industry

Medical Equipment Manufacturing

Description

Description Position Summary The Quality Assurance Specialist plays a vital role in planning, executing, and supervising inspection and testing activities related to the approval and release of components, sub-assemblies, and finished devices in accordance with established Standard Operating Procedures and/or drawings. This position ensures accuracy, thoroughness, and adherence to specifications by reviewing Device History Record (DHR) data entries according to relevant departmental procedures and promptly identifies and reports any deviations within the quality management systems. The Quality Assurance Specialist is responsible for maintaining DHR records, raising nonconformance records as needed to address any discrepancies. Additionally, the role involves supporting the implementation of procedure revisions, corrections, and method changes to enhance quality assurance processes. Job Duties/Responsibilities Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables. Plan, execute, and oversee final product inspections and product release activities. Follows detailed procedures documented in SOP's, work instructions, forms and on check lists. Provide training and support to QA team members covering incoming inspections, DHR reviews and environmental monitoring. Initiates and mange non-conforming material reports from identification to resolution. Plan, execute, and oversee Environmental monitoring of the Cleanroom and Gowning room. Perform functional and/or dimensional testing of engineering studies and validation protocols. Participates in regular on-site or remote audits of our suppliers to assess their compliance with contractual agreements, quality management systems, industry regulations, and our company's standards. Participate in periodic reviews of all documents to maintain consistency to customer requirements, SOPs and changes or improvements to processes. Ensure the manufacturing facility procedures comply with SOPs and applicable GMPs and ISO standards and comply with customer requirements. Ensure consistency/compliance of document structure and compliance with established SOPs, ISO standards and applicable cGMP. Provide training and support to quality team members that cover systems, policies, procedures, and core processes. Observes discussions to learn about corrective actions for reoccurring problems. Engages in discussions about corrective actions for reoccurring problems. Embodies process management principles for effective process administration. Embodies the Company’s purpose and shared values, 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. Other duties as assigned. Requirements Qualifications Associate’s degree in technical or business-related field / Bachelor’s degree preferred. Minimum of 2 years 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 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. Experience with environmental monitoring testing a plus. 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, Outlook and PowerPoint). Willingness to work a flexible schedule. Able to travel for work as needed. Satisfactorily pass comprehensive background screening. Physical Demands/Working Conditions Works in office space, supply room, laboratory, and/or clean room environments. Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals. Requires frequent finite hand/eye coordination. Largely a stationary role with some moving from place to place. Frequent use of a computer, keyboard, mouse, monitor and other office equipment. Frequent use of laboratory and manufacturing equipment. Frequently picks up, carries, and moves items up to 50 lbs. Some evening and weekend work depending upon workload. Some overnight travel may be required for work, events, and training.

Responsibilities

The Quality Assurance Specialist plans and executes product inspections, testing, and release activities while ensuring compliance with SOPs and regulatory standards. They also manage nonconformance records, perform environmental monitoring, and support quality system improvements.