Quality Assurance Document Specialist

6 days ago


Houston, Texas, United States Healgen Scientific Limited Full time
Job Description

We are seeking a highly skilled Compliance Document Specialist for Quality to join our team at Healgen Scientific Limited.

About the Role

The successful candidate will be responsible for maintaining proper documentation practices to ensure compliance with FDA, ISO, and other regulatory requirements. This includes drafting new documents, reviewing records, and ensuring completed documentation meets internal quality standards.

Key Responsibilities
  1. Collaborate with cross-functional teams to ensure all documents are properly stored and archived.
  2. Facilitate periodic review of documents to comply with internal QMS requirements.
  3. Draft documentation for batch records and raw material specifications.
  4. Draft procedures for technical processes.
  5. Data entry and basic statistical analysis.
  6. Support the Internal Quality Audit program.
  7. Inspect raw materials, in-process, and finished products.
  8. Assist manufacturing with batch release and other relevant documentation.
  9. Contribute to post-market monitoring of our products.
  10. Provide technical expertise and support training as required.
  11. Participate in supplier quality checks.
  12. Maintain accurate documentation of incoming and outgoing product.
Requirements
  1. A minimum of 2 years of relevant experience and a relevant bachelor's degree, or 5 years of experience without a degree, preferably in the Medical Device industry.
  2. Excellent communication skills in written and spoken English.
  3. Ability to work effectively in a cross-functional team on an international stage.
  4. Strong analytical and troubleshooting skills.
  5. Prioritize tasks effectively and show initiative in daily tasks.
  6. Bilingual individuals who can speak and write Chinese, Spanish, French, or German are preferred.

This is an onsite position.



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