Compliance Document Specialist for Quality

4 days ago


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

We are seeking a skilled Document Control and Compliance Specialist to join our team at Healgen Scientific Limited.

About the Role

The successful candidate will ensure compliance with regulatory requirements by drafting new documents, reviewing records, and maintaining accurate documentation practices.

Key Responsibilities
  1. Maintain compliance with FDA, ISO, and other regulatory requirements.
  2. Collaborate with cross-functional teams to store and archive documents.
  3. Draft documentation for batch records, raw material specifications, and technical processes.
  4. Support data entry and statistical analysis.
  5. Participate in the Internal Quality Audit program.
  6. Inspect raw materials, in-process, and finished products.
  7. Support manufacturing with batch release and other documentation.
  8. Contribute to post-market monitoring of our products.
  9. Provide technical expertise and support training.
  10. Participate in supplier quality checks.
  11. 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 role offers a competitive salary range of $65,000 - $80,000 per annum, depending on experience.



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