Senior Quality Assurance Engineer

Senior Quality Assurance Engineer Autonomous Medical Devices Incorporated
• Santa Ana, CA, US

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.

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.

• 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., ISO
  13485 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.

• Bachelor's degree in engineering, science or related field required;
  Advanced degree preferred.
• A minimum of 7 years of Quality engineering experience in medical device industry, with at least 2 years in new product design and development.
• Hands-on experience with design control processes, and mastery knowledge of ISO 13485:2016 and 21 CFR Part 820.
• Hands-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…