QUALITY & DOCUMENT CONTROL SPECIALIST

Galaxy Therapeutics; Milpitas (CA); On-site; USD 39,000 - 55,000; Full time

Job summary

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.

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 emphasizes FDA- and ISO-regulated quality practices.

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.

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.

Job description

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.