Autonomous Medical Devices Incorporated · 3 months ago
Senior Quality Assurance Engineer
Santa Ana, CA, US
Full-time
Onsite
Senior Level
$100K/yr - $135K/yr
7+ years expAutonomous Medical Devices Incorporated (AMDI) is a California-based company dedicated to the development and manufacture of diagnostic devices. They are seeking a Senior Quality Assurance Engineer to ensure products meet safety and compliance standards, collaborating with R&D, Engineering, and Operations.
BiotechnologyHospitalInformation TechnologyMedical Device
Responsibilities
Provides QA guidance and support throughout the entire design control and product realization processes to ensure that medical device/products meet all applicable regulations and standards (e.g., ISO13485 requirements, 21 CFR Part 820, other applicable FDA regulations and guidance documents, applicable ISO and IEC standards, and regulations of applicable global regulatory authorities)
Works closely with R&D, Engineering and Operations to support new product development and improve product design
Leads risk management activities, e.g., creating or reviewing risk management plans, risk assessment documents and risk management reports
Writes, or reviews validation protocols and reports
Work with supplier quality and supply chain groups to ensure product suppliers are effectively developed
Verifies configuration management and Risk Analysis records are properly addressed, accurate, and maintained
Supports software development activities to ensure compliance with applicable regulations and standards
Leads design transfer activities pertaining to product quality and regulatory compliance
Ensures design changes are processed in accordance with current change control requirements
Participates in and support other QMS processes, e.g., conducting NCR investigations, leading CAPA processes, conducting internal audits, supporting process validations
Completes assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for product development activities
Coordinates resolution of potential quality assurance deficiencies discovered during the product realization process
Additional projects and/or duties as assigned
Qualification
Required
Bachelor's degree in engineering, science or related field required
A minimum of 7 years of Quality engineering experience in medical device industry, with at least 2 years in new product design and development
Hand-on experience with design control processes, and mastery knowledge of ISO 13485:2016 and 21 CFR Part 820
Hand-on experience with risk management and mastery knowledge of ISO 14971
Well organized and attentive to detail
Strong documentation skills, i.e., excellent skills in writing clear, concise and logical verification/validation/qualification protocols and reports, work instructions, and investigation reports
Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within colleagues and suppliers
Ability to interpret trends and data, translating the information into actions and improvements
Strong verbal and written communication skills
Proficient with QMS software. Tech-savvy and able to learn new software easily
Preferred
Advanced degree preferred
Contributes to a collaborative and inclusive work environment
Results oriented – drives progress & excellence
Someone who has high standards, takes ownership, and is invested in the outcome
Someone who proactively helps others and stays positive
Experience with software development and software V&V activities, and mastery knowledge of ISO, IEC and FDA requirements for software
IVD medical device experience
Quality engineering certification (ASQ CQE or CQA) desired
Benefits
Company provided lunch to all employees when working at one of AMDI’s on-site locations.
401(k) match
Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance
Competitive vacation, sick days & paid holidays
Tuition reimbursement
Casual dress code
Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.
Monthly company-wide socials and activities
Company
Autonomous Medical Devices Incorporated
Autonomous Medical Devices Incorporated (AMDI), with its principal place of business in California, employs a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of point-of-care diagnostic devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity.
51-200 employees
H1B Sponsorship
Autonomous Medical Devices Incorporated 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 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$148MKey Investors
National Institute of Biomedical Imaging and Bioengineering
2024-02-28Grant· $5.3M
2023-04-12Grant· $1.2M
2021-03-08Series Unknown· $121.5M
Leadership Team
David Okrongly
CEO
Rafael Delgado
HR Business Partner
Recent News
2025-09-15
BioWorld Financial Watch
2025-06-09
Company data provided by crunchbase