Astrix · 13 hours ago
Quality Engineer I
Irvine, CA
Full-time
Onsite
Entry, Mid Level
$65K/yr - $75K/yr
2+ years expAstrix is a global medical device company specializing in vision/surgical care products, and they are seeking a Quality Engineer to help ensure the highest standards in manufacturing and product performance for medical devices. The role involves developing quality control plans, leading investigations into quality issues, and ensuring compliance with regulatory requirements.
ConsultingInformation Technology
Responsibilities
Develop and implement plans to maintain quality control and ensure product conformance throughout manufacturing processes
Lead investigations into production and customer-facing quality issues, identifying root causes and implementing corrective and preventative actions (CAPAs)
Monitor and analyze product performance using statistical and risk-based approaches, evaluating potential quality, compliance, customer, and business risks
Perform hands-on troubleshooting of returned devices and manufacturing nonconformities, completing associated technical documentation
Create tools and reports to communicate complex technical problems and solutions to diverse audiences across the organization
Apply project management, data analysis, root cause analysis, and risk determination skills to support quality initiatives
Ensure compliance with internal Quality System policies and external regulatory requirements, including FDA, ISO 13485, and other applicable standards
Qualification
Required
Bachelor's degree in Engineering
2+ years of relevant experience in a regulated industry (experience in FDA-regulated environments preferred)
Knowledge of FDA regulations (21 CFR Part 820 and Part 803) and ISO 13485 standards
Company
Astrix
Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.
1001-5000 employees
H1B Sponsorship
Astrix 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 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)
Funding
Current Stage
Late StageLeadership Team
Dale Curtis
Chief Executive Officer
Reid E. Simpson
Chief Financial Officer
Recent News
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