STAAR Surgical · 12 hours ago
Quality Engineer I
Monrovia, CA
Full-time
Onsite
Entry Level
$70K/yr - $90K/yr
2+ years expSTAAR Surgical is a company focused on innovative medical devices, and they are seeking a Quality Engineer I to support production, operations, and quality teams. The role involves addressing emergent issues, leading investigations, preparing validations, and supporting audits and project teams in ensuring quality standards are met.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
Support site production, operations, and quality and R&D teams by addressing emergent issues that might arise due to the operation processes. Serve as the quality representative during any product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities
Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports
Support project teams on non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action and SCRs
Support internal audits and supplier audits. This includes preparation of audit plans, audit reports, and verifying SCRs have been completed
Support project teams on Corrective Action/Preventive Action (CAPA) projects. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure and conduct effectiveness checks (EC)
Assist Complaint Handling Department with technical/engineering support regarding customer complaints and product returns. Investigation may involve reviewing manufacturing batch records, vendor component records, MRB records, etc. to determine root cause of product failure
Prepare and report appropriate metrics to Quality management
Participate in Design Project Teams as a QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Additionally, ensure that quality related issues are adequately addressed. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements
Support internal team during audits at Monrovia sites; participate in the preparation and completion of corrective action plans as needed
Other duties as assigned
Qualification
Required
Bachelor's degree, preferably in science or engineering or equivalent combination of education/experience
Two years' experience or advanced degree with one year of experience in quality engineering in the medical device or pharmaceutical industries is preferred
Solid understanding of investigation techniques including design of experiments and root cause analysis
Solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis
Excellent project management, organization, writing and presentation skills required
Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point
Must be highly proficient in written and verbal communication
Preferred
General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization
Company
STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye.
501-1000 employees
H1B Sponsorship
STAAR Surgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (8)
2023 (6)
2022 (10)
2021 (2)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown2025-08-05Acquired
1990-11-02IPO
Leadership Team
Keith Holliday
Chief Technology Officer
Recent News
2026-02-02
2026-01-16
Company data provided by crunchbase