Senior Quality Assurance Specialist

Job Description

Job DescriptionDescription:

Company Overview

The journey for a patient with a brain tumor is deeply emotional. Newly diagnosed patients often arrive at the emergency department due to changes in vision, balance, or cognitive function. Their world is quickly turned upside down as they race towards surgery. Unfortunately, many patients (~50% for glioblastomas) experience recurrence within a few months and, along with their dedicated family members and clinicians, must navigate treatment options once again. It has been over a decade since an innovative treatment option was cleared by the FDA—until GammaTile® Therapy!

GT Medical™ Technologies exists to provide a better option for these patients, caregivers, and clinicians. Guided by our Shared Values of Empathy, Empowerment, and Excellence, we strive to make a meaningful difference. Our Corporate Purpose is to Improve the Lives of Patients with Brain Tumors, and this mission drives us daily.

GammaTile® Therapy is supported by over 100 incredible teammates who collaborate organically, challenge appropriately, and are consumed with helping the next patient. With a goal growth rate of over 30% per year in orders, revenue, and clinical trial enrollments, our progress is encouraging, and we are aiming for even better results this year. We have a great core team, an innovative solution, and the resources to support further growth.

We are now seeking a Senior Quality Assurance Specialist to add to our growing Quality team. This individual will be located onsite in Richland, WA. If you have a heart for patients with brain tumors, the passion for quality assurance, strong problem-solving skills, and tactical execution, we’d love to talk to you!

Position Summary

The Senior Quality Assurance Specialist plays a key role in ensuring that products are developed, manufactured, and released in compliance with applicable quality and regulatory standards. This position is responsible for driving continuous improvement initiatives and providing quality oversight across cross-functional teams involved in the design, manufacturing, and testing of medical devices. Additionally, this role contributes to the overall health of the quality management system through the completion of process audits, continuous improvement projects, and monitoring of key process indicators.

Job Duties/Responsibilities

• Accountable for managing quality support activities for manufacturing and act as key quality contact for discrepancy management including Nonconformance (NC) and Corrective Action/Preventive Action (CAPA) systems.
• Ensure compliance with applicable regulations (FDA 21 CFR, ISO 13485, and other applicable domestic and global standards.
• Ensure that NC/CAPA investigations are accurate, include appropriate corrections, problem statement, root cause analysis, corrective/preventive actions, follow regulations, industry guidelines and company standards.
• Update the eQMS system for logging NC/CAPA and execute on deliverables to drive improvements.
• Manage key performance indicators (KPI’s) and present results to management and other stakeholders.
• Develop tools for and perform internal process audits to assess compliance with standard operating procedures.
• Support external notified body audits and FDA inspections as a technical resource and quality subject matter expert.
• Provide quality oversight related to operational activities, procedures, and processes including review and approve validation protocols, calibration records, analytical reports, and equipment maintenance records.
• Create and improve processes for quality and compliance using in-depth knowledge in the manufacturing and quality functional areas.
• Monitor and evaluate process controls, supplier quality, and product conformity.
• Provide quality systems, policy, and process training and support to team members.
• Lead quality issue resolution across manufacturing operations, support groups, and/or projects as needed.
• Embody the Company’s purpose and shared values, building a positive and productive team culture.
• Comply with Company policies and procedures.
• Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
• Other duties as assigned.

Requirements:

Qualifications

• Bachelor’s degree preferably in life sciences, engineering, or related field or the equivalent combination of education and experience.
• Minimum of 8 years of experience working in quality assurance required.
• Experience in the medical device or pharmaceutical industry required.
• Solid understanding of regulatory requirements in medical device manufacturing according to FDA 21CFR, ISO 13485, and MDSAP required.
• Good Manufacturing Practices certification required.
• Strong analytical and problem-solving skills and demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.
• Possess a deep understanding of quality systems and quality assurance concepts.
• Previous work experience in a radiologically safe environment preferred.
• Must be excellent with details and possess strong documentation and organizational skills.
• Ability to collaborate effectively and tactfully regarding complex and sensitive information.
• Ability to establish and maintain effective working relationships relevant with cross functional teams.
• Ability to multi-task and work within deadlines.
• Ability to read and interpret Standard Operating Procedures (SOPs) and work instructions.
• Must be able to perform basic mathematical functions using whole numbers, fractions, and decimals and compute averages, rates, percentages, and draw and interpret graphs.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Outlook, Word, Excel, and PowerPoint).
• Willingness to work a flexible schedule.
• Able to travel for work as needed.
• Satisfactorily pass comprehensive background screening.
• Satisfactorily pass drug screening (if applicable to position).

Physical Demands/Working Conditions

• Works in office space, supply room, laboratory, and/or clean room environments.
• Some exposure to hazardous materials requiring appropriate PPE and precautions.
• Largely a stationary role with some moving from place to place.
• Frequent use of a computer, keyboard, mouse, monitor and other office equipment.
• Occasionally picks up, carries, and moves items up to 30 lbs.
• Infrequent evening and weekend work may be required as needed.
• Some overnight travel may be required for work, events, and training.