Senior Quality Specialist

3 weeks ago

Milpitas, United States Galaxy Therapeutics Full time

ABOUT GALAXY THERAPEUTICS INC.

Galaxy Therapeutics is a private, US-based, clinical stage medical device company. We have a proprietary implant technology to treat brain aneurysms. Brain aneurysms occur in up to 6% of the population. Up to half of brain aneurysms require treatment. This is over a $1B Market Opportunity. We are addressing this opportunity with the Saccular Endovascular Aneurysm Lattice treatment system: SealTM. Galaxy is currently at an early clinical stage. We have successfully demonstrated proof of concept, and clinical safety with our Pre SEAL IT trial which enrolled 33 patients at multiple sites. Safety, efficacy and durability has been demonstrated in all patients. We are currently working with FDA to launch our Pre-Market approval SEAL-IT trial in US and internationally. Galaxy holds multiple patents in US, EU, China and other markets. Founded by four practicing neuro interventional physicians. Our core team is based in Milpitas, CA.


ABOUT THE ROLE

The Senior Quality Specialist plays a crucial role working under the direction of the quality executive to oversee quality control and assurance activities. This includes implementing standard procedures, ensuring proper documentation, and managing internal and external quality audit processes. With a focus on maintaining high-quality standards, the Senior Quality Specialist contributes to the overall success of the organization by ensuring adherence to established protocols and regulations.


ROLE RESPONSIBILITIES

  • Administer the document change control process, managing the release and maintenance of controlled documents such as policies, procedures, work instructions, forms, and component specifications.
  • Review change requests to ensure compliance with internal requirements.
  • Conduct inspections based on well-defined criteria, utilizing standard physical, mechanical, and/or electrical measurements.
  • Accurately document inspection and testing results, maintaining timely and accurate records of controlled documents and test records.
  • Review device history records for completeness and accuracy.
  • Perform component and product testing according to defined test methods, including standard physical and mechanical evaluations.
  • Conduct inspections and evaluations in various areas, such as component evaluation, finished product testing, and returned product analysis.
  • Review Environmental Monitoring of Controlled Environment Reports.
  • Monitor equipment and instrumentation to ensure proper operation and calibration.
  • Evaluate problems and provide initial recommendations for possible corrective actions to supervisors.
  • Contribute to the organization and management of the laboratory.
  • Perform additional duties as assigned to support the overall success and objectives of the company.


QUALIFICATIONS AND SKILLS

  • High School Diploma and at least 6 years of experience OR Technical Certificate and 3 years of experience.
  • Knowledge of Good Manufacturing Practices (GMP).
  • Experience in interacting with outside vendors and contractors.
  • Proficiency in using general-purpose laboratory equipment, methods, and practices related to product development and manufacturing.
  • Familiarity with personal computers and standard office software applications.
  • Ability to troubleshoot down to the component level.
  • Basic writing skills for creating test protocols and reports using guidance documentation or templates.
  • Proficiency in using basic and complex tools in the lab area.

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