Quality Assurance Specialist

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

Job summary

Healgen Scientific Limited is seeking a QA Specialist with a strong grasp of FDA guidelines and ISO 13485 to oversee quality systems for medical devices. This role supports development, implementation, and maintenance of QA processes across manufacturing and distribution channels.

The ideal candidate will coordinate CAPAs and audits, assist in investigations, and ensure regulatory compliance while guiding document control, training, and supplier management.

Qualifications

• Bachelor's degree in a relevant field or 5+ years' experience without degree.
• Able to work with cross-functional teams on an international scale.
• Excellent written and spoken English.
• Able to troubleshoot problems as needed.
• Able to prioritize tasks effectively.
• Show initiative and be proactive in day-to-day tasks.
• Preference for bilingual individuals: Chinese or Spanish.

Responsibilities

• Work with cross-functional team to ensure documents are stored and archived.
• Support and track quality events such as CAPAs, SCARs, Non-conformances, Deviations, Reworks and Customer Complaints.
• Support investigations and root cause analyses.
• Facilitate document control and change control by initiating and completing COs.
• Coordinate with process owners to update procedures and draft documentation.
• Ensure completed documentation meets internal quality standards.
• Data entry and basic statistical analysis.
• Support during internal and external regulatory audits.
• Inspect raw materials, in-process, and finished products.
• Assist manufacturing with batch release and related documentation.
• Assist with post-market monitoring of products.
• Create and track training events to keep records up to date and compliant.
• Support supplier evaluations and maintenance of the Approved Supplier List.
• Assist in other duties.

Skills

Team collaboration

English communication

Troubleshooting

Task prioritization

Proactive mindset

Bilingual (Chinese/Spanish)

Education

Bachelor's degree in a relevant field

5+ years of relevant experience without degree

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.

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.