Overview
Director of Quality – Ophthalmology Jobs in United States at Atrio Search
Title: Director of Quality – Ophthalmology
Company: Atrio Search
Location: United States
Director of Quality – Ophthalmic Devices
We are seeking an experienced Director of Quality to lead quality systems, compliance, and continuous improvement initiatives for our ophthalmic device business in the U.S. This role will oversee quality operations across product development, manufacturing, supplier quality, and post-market activities to ensure our products meet the highest standards of safety, performance, and regulatory compliance.
Key Responsibilities
- Lead the company’s Quality Management System in alignment with applicable regulatory and industry standards.
- Oversee quality assurance, quality control, and compliance activities across the product lifecycle.
- Drive CAPA, complaint handling, nonconformance investigations, and root cause analysis.
- Partner with engineering, manufacturing, regulatory, and supply chain teams to support product quality and operational excellence.
- Manage internal audits, supplier audits, and readiness for external regulatory inspections.
- Evaluate trends in defects, process variation, and customer feedback to identify improvement opportunities.
- Support validation, verification, and release activities for new and existing ophthalmic devices.
- Develop and mentor quality team members, promoting a culture of accountability and continuous improvement.
- Ensure documentation, training, and recordkeeping practices meet internal and external requirements.
- Collaborate with leadership on quality strategy, risk management, and business priorities.
Qualifications
- Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.
- 8+ years of experience in quality assurance or quality management within medical devices.
- Strong experience in ophthalmic devices strongly preferred.
- Experience with lenses, refractive lasers, cataract lasers, and other relevant ophthalmic technologies strongly preferred.
- Additional relevant experience with IOLs, surgical visualization systems, diagnostic ophthalmic equipment, excimer lasers, femtosecond lasers, and related ophthalmic capital equipment is highly valued.
- Strong working knowledge of FDA quality system requirements, ISO 13485, and medical device regulations.
- Demonstrated experience with audits, CAPA, complaint handling, supplier quality, and change control.
- Proven leadership experience managing cross-functional quality initiatives.
- Excellent communication, problem-solving, and organizational skills.
Preferred Experience
- Class II or Class III medical device background.
- Experience supporting both development-stage and commercialized products.
- Familiarity with sterilization, packaging, or hardware/software quality systems.
- Prior experience leading quality teams in a growth-stage environment.
- Experience with ophthalmic device design controls and risk management.
