Quality Assurance Specialist

Job overview

The Quality Assurance Specialist role is onsite in Houston, TX. The salary range is $60,000–$75,000 per year. The role supports quality assurance processes for the development, manufacturing, and distribution of medical devices at Healgen Scientific Limited. The specialist helps maintain compliant quality systems by managing quality events and documentation, supporting investigations and audits, inspecting products, and assisting with training records and supplier oversight.

What you'll do

• Maintain and archive quality documents
• track CAPAs, SCARs, non-conformances, deviations, reworks, and customer complaints
• support investigations and root-cause analyses
• facilitate document and change control
• coordinate procedure updates
• perform data entry and basic statistical analysis
• support regulatory audits
• inspect raw materials and products
• assist with batch release documentation and post-market monitoring
• maintain training records
• and support supplier evaluations.

What we're looking for

Skills & competencies

quality assurance specialist

houston tx

healgen scientific limited

medical devices

fda guidelines

iso 13485

capa

document control

regulatory audits

product inspection

$60,000–$75,000

supplier evaluations

Work arrangement

• Weekend coverage required

Why this role

The posting seeks at least two years of relevant experience and a relevant bachelor’s degree, or at least five years of relevant experience without a degree. Chinese or Spanish language skills are preferred.

About the employer

Healgen Scientific Limited is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.