QUALITY & DOCUMENT CONTROL SPECIALIST

Galaxy Therapeutics is seeking detail-oriented professionals to support our Quality Assurance, Quality Control, document control, inspection, and manufacturing quality activities as we expand our neurovascular medical-device operations. About the Role We are recruiting at multiple levels, from a Document Control Clerk to experienced Quality Technicians/Specialists with hands-on inspection and medical-device QMS experience. This position is particularly important as Galaxy expands manufacturing activities and prepares for broader commercialization under an FDA- and ISO-regulated quality system. Responsibilities Document Control Maintain controlled quality and manufacturing documents. Support document issuance, revision, distribution, and archival. Maintain document-control records and databases. Ensure obsolete documents are appropriately controlled. Support SOP, work instruction, form, and specification revisions. Maintain accurate electronic and paper records as required. Support training-documentation activities. Assist with Device History Record and manufacturing documentation review. Ensure documentation is complete, legible, accurate, and traceable. Support audits and regulatory inspections by retrieving controlled documentation. Quality Technician / Specialist Perform incoming, in-process, and final inspections. Inspect components and finished medical devices against established specifications. Perform dimensional and visual inspections. Use appropriate inspection tools and equipment. Document inspection results accurately. Identify nonconforming materials and products. Support NCR/nonconformance investigations. Assist with CAPA and quality investigations. Review manufacturing documentation for completeness and compliance. Support supplier and incoming inspection activities. Work closely with Manufacturing and R&D to identify and resolve quality issues. Support internal and external audits. Maintain compliance with applicable FDA and ISO 13485 requirements. Assist with implementation and maintenance of the Quality Management System. Qualifications Medical-device quality experience strongly preferred. Experience with ISO 13485 Quality Management Systems preferred. Familiarity with FDA-regulated medical-device documentation. Experience with incoming, in-process, and final inspection preferred. Strong attention to detail. Ability to identify discrepancies and defects. Ability to follow controlled procedures. Experience with inspection tools and measurement equipment preferred. Strong organizational skills. Dependable and capable of working independently. Strong communication and teamwork skills. Startup Environment This position requires flexibility. Depending on experience and workload, the individual may support activities beyond traditional quality/document-control responsibilities, including assembly support, inspection, kitting, manufacturing documentation, inventory-related activities, and other production-support functions. Only candidates with relevant medical device experience who meet the qualifications above will be considered. Pay range and compensation package Quality Technician / Specialist: $28–$40/hour Equal Opportunity Statement Galaxy Therapeutics is committed to diversity and inclusivity in the workplace. #J-18808-Ljbffr