Quality Assurance Specialist - Medical Devices & Compliance

Healgen; Houston (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Healgen Scientific is seeking a Quality Assurance Specialist to drive compliance with FDA guidelines and ISO 13485 across our medical device products. You will support CAPAs, change control, audits, and post‑market monitoring while collaborating with cross‑functional, international teams to ensure robust quality systems.

Strong English communication, data entry, and basic statistical analysis are required, with a preference for bilingual candidates (Chinese or Spanish).

Qualifications

• Have at least 2 years of relevant experience and a relevant bachelor’s degree OR at least 5 years of relevant experience without a degree, preferably in the Medical Device or Pharmaceutical industry.
• Be able to work with a cross-functional team on an international stage.
• Be able to communicate effectively in written and spoken English.
• Be able to troubleshoot as necessary.
• Be able to prioritize tasks effectively.
• Show initiative and be proactive in their day-to-day tasks.
• Preference for bilingual individuals that can speak and write Chinese or Spanish.

Responsibilities

• Work with a cross-functional team to ensure all documents are properly stored and archived.
• Support and track Quality related events such as CAPAs, SCARs, Non-conformances, Deviations, Reworks and Customer Complaints.
• Supports investigations and root cause analyses.
• Facilitate document control and change control process by initiating and completing CO’s.
• Coordinate with process owners to update procedures and draft documentation as required.
• Ensure completed documentation meets internal quality standards.
• Data entry and basic statistical analysis.
• Support during Internal and External regulatory audits.
• Inspection of raw material and in-process and finished products.
• Assist manufacturing with batch release and other relevant documentation.
• Assist with post-market monitoring of the company’s products.
• Creates and keeps track of training events to ensure employee training records are up to date and compliant.
• Support with supplier evaluations and maintenance of the Approved Supplier List.
• Assist in other duties as assigned by the QA Supervisor.

Skills

Cross-functional teamwork

English communication

Troubleshooting

Task prioritization

Initiative

Bilingual Chinese/Spanish

Education

Bachelor's degree

Job description

Healgen Scientific is seeking a Quality Assurance Specialist to drive compliance with FDA guidelines and ISO 13485 across our medical device products. You will support CAPAs, change control, audits, and post‑market monitoring while collaborating with cross‑functional, international teams to ensure robust quality systems.

Strong English communication, data entry, and basic statistical analysis are required, with a preference for bilingual candidates (Chinese or Spanish).