Senior Quality Assurance Engineer

Autonomous Medical Devices Incorporated (AMDI)  is a California-based company employing a world class team of engineers, scientists, clinicians, manufacturing and quality / regulatory experts dedicated to the development and manufacture of best in class diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA where it manufactures the Fast PCR Mini Respiratory Panel in an ISO : 13485 / MDSAP certified 110,000 square foot facility.

Summary of Position

Are you a detail-driven professional with a passion for quality and innovation in medical devices? We are seeking a Senior Quality Assurance (QA) Engineer to join our team! As a key member of the Quality team, you will play a critical role in ensuring that our products meet the highest standards of safety, effectiveness, and compliance. The Senior QA Engineer will provide guidance and support across all phases of design control and product realization, collaborating closely with R&D, Engineering, and Operations. The ideal candidate will bring expertise in regulatory standards and quality systems to help shape product development, improve design processes, and maintain robust documentation.

Location : This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred.

Essential Duties and 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.

Qualifications Required for Position

Desired skills and traits

Work Environment

Salary Range

The estimated base salary range for this position is $100,000 - $135,000 annually . If the level of the role changes during the hiring process, the applicable base pay range may be updated accordingly. The actual base salary offered will be determined by several factors, including, but not limited to, the applicant's qualifications for the position, years of relevant experience, distinctive skills, and level of education attained.

Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including :

Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts.

Our commitment to an inclusive workplace :

We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.