Overview
QUALITY & DOCUMENT CONTROL SPECIALIST Jobs in Milpitas, CA at Galaxy Therapeutics
Title: QUALITY & DOCUMENT CONTROL SPECIALIST
Company: Galaxy Therapeutics
Location: Milpitas, CA
About the Company
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.
- Excellent documentation skills.
- 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
- Document Control Clerk: $28–$38/hour
- Quality Technician / Specialist: $28–$40/hour
Equal Opportunity Statement
Galaxy Therapeutics is committed to diversity and inclusivity in the workplace.
