Ophthalmic QA Engineer: Validation & Compliance

BVI Medical, Inc.; Sarasota (FL); On-site; USD 70,000 - 105,000; Full time

Job summary

BVI Medical, Inc. is seeking a Quality Engineer to support ophthalmic medical device manufacturing from development through production.

You will design and execute validation/qualification tests on processes, equipment, and software to ensure compliance with ISO 13485 and FDA regulations. The role requires a bachelor’s in Engineering or Biomedical Engineering and at least two years of related experience, with hands-on CDS software and QMS tools like EtQ or TrackWise.

Qualifications

• Bachelor's degree in Engineering or Biomedical Engineering.
• 2+ years of quality and validation support in medical device R&D/manufacturing.
• Experience with CDS software, CAPA, and quality events using EtQ or TrackWise.

Responsibilities

• Provide quality and validation support to R&D of ophthalmic medical device manufacturing processes and products.
• Ensure product quality throughout manufacturing from design to delivery.
• Lead CAPA investigations and manage CAPA workflows with EtQ or TrackWise.

Skills

CAPA

EtQ

TrackWise

CDS

IQ/OQ/PQ

Quality Systems

Education

Bachelor's in Engineering / Biomedical Engineering

Tools

LabWare LIMS

Water Empower

Job description

BVI Medical, Inc. is seeking a Quality Engineer to support ophthalmic medical device manufacturing from development through production.

You will design and execute validation/qualification tests on processes, equipment, and software to ensure compliance with ISO 13485 and FDA regulations. The role requires a bachelor’s in Engineering or Biomedical Engineering and at least two years of related experience, with hands-on CDS software and QMS tools like EtQ or TrackWise.