AccuMedical USA Inc. is looking for a Sr. Quality Engineer to join our innovative and dynamic team in Costa Mesa, California.
AccuMedical is focused on developing innovative therapies for neurovascular products that will address global, unmet medical conditions and patient needs. As a thriving small company with a multinational team, we work in a fast-paced international environment, empowering our team members to take initiative, make decisions and lead with opportunities to excel and grow in their expert fields. We foster a work/life balance with the dedication to the wellness of our employees.
Essential Responsibilities of the Senior or Principal Quality Engineer for Risk Management include:
Act and represent as the SME for risk management activities with overall responsibilities to establish, maintain, and oversee RMFs (Risk Management Files) throughout the product lifecycle.
Chair or lead routine Risk Management meetings and actively engage cross-functional team members
Establish, implement, maintain and update risk management procedures, templates, protocols, and reports.
Owner and author of the product risk documents that provide planning, identifying, estimating, risk status as well as risk control and mitigation approaches/methods.
Plan and perform the management of risk for new products as part of the New Product Development (NPD) activities and processes.
Perform and document the risk management reviews as well as actively communicate results of the risk management as a part of the design and development phases to cross-functional teams (e.g., Quality, Regulatory, Clinical, R&D, and Operations teams).
Collaborate with the marketing, clinical, regulatory, medical safety/medical affairs, manufacturing, New Product Development (NPD) R&D team and other functional teams to establish risk documents that are in compliance with applicable risk standards.
Ensure that hazards associated with products are identified, estimated, evaluated, controlled, documented, and monitor that the risk controls are implemented, verified, and validated for products in development.
Assure the timely delivery of risk management deliverables in support of new product development activities and plan for post-market risk monitoring as needed to ensure risk management files are maintained throughout the product lifecycle.
Develop and maintain Post Market Surveillance programs
Perform reviews of Instruction For Use (IFU), clinical investigation documentation, Risk Management Reports (RMR), Usability and Human Factor Risk Report, Clinical Evaluation Report (CER), Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performance (SSCP) to ensure identified risk information harmonizes
Identify opportunities for continuous improvement of the Risk Management Process
Responsible for ensuring the product risk activities comply with ISO 13485, ISO 14975, ISO/TR 24971/2020
Support Regulatory with related risk documentation for global regulatory activities to enable a global product launch
Education and Experience:
Must be eligible to work in the U.S. and not require visa sponsorship
Bachelor’s Degree in Engineering or another Scientific discipline with a minimum of 8-10 years of experience preferable in US Class II or US Class III medical devices (development or commercial)
Have an extensive hands-on experience with the 21 CFR 820, ISO 14971, ISO 13485, ISO 14975, ISO/TR 24971/2020, IEC 62366 standard, EU MDD and EU MDR.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Working knowledge and understanding of statistical techniques
Strong technical writing, documentation, communication, and interpersonal relationship skills
Six Sigma Green/Black belt preferred
Strong understanding of risk management requirements as well as the use of tools, methodologies, and processes, including the use of a variety of accepted methods
Have previous experience in leading complex projects and driving cultural change.
Experience working within a Quality Management System