Quality Assurance Specialist

Healgen Scientific; Houston (TX); On-site; USD 60,000 - 75,000; Full time

Job summary

Healgen Scientific Limited, located in the Houston, TX area, seeks a QA Specialist with strong FDA guidelines and ISO 13485 knowledge to support quality systems for medical devices. This full-time, in-office role focuses on building and maintaining QA processes, ensuring regulatory compliance, and coordinating cross-functional activities.

Responsibilities include CAPA tracking, audits, document control, investigations, and training management.

Qualifications

• 2+ years of relevant experience or 5+ years without degree in Medical Device/Pharmaceutical
• Cross-functional team collaboration
• Strong written and spoken English communications
• Ability to troubleshoot when needed
• Ability to prioritize tasks effectively
• Proactive and takes initiative in daily tasks
• Bilingual candidates with Chinese or Spanish preferred

Responsibilities

• Archive and store documents with cross-functional team
• Support and track CAPAs, SCARs, non-conformances, deviations, reworks and customer complaints
• Assist investigations and root cause analyses
• Manage document control and change control processes
• Coordinate with process owners to update procedures and draft docs
• Ensure documentation meets internal quality standards
• Data entry and basic statistical analysis
• Support internal and external regulatory audits
• Inspect raw materials, in-process and finished products
• Assist manufacturing with batch release documentation
• Support post-market monitoring of products
• Create and track employee training records
• Assist supplier evaluations and maintenance of Approved Supplier List
• Other duties as assigned

Skills

Quality Assurance

Document Control

CAPA

Root Cause Analysis

FDA Regulations

ISO 13485

Cross-functional teamwork

English Communication

Training Coordination

Supplier Evaluation

Education

Bachelor's degree in relevant field

Job description

Salary Range: $60,000.00 To $75,000.00 Annually

The ideal QA Specialist candidate would have a strong understanding of FDA guidelines and ISO 13485 regulations to ensure compliance and uphold product quality standards. The Quality Assurance Specialist will play a critical role in the development, implementation, and maintenance of quality assurance processes and systems to support the manufacturing and distribution of medical devices.

This is a fulltime in office position located in the Houston, TX area.

Duties and 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.

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.