Principal Quality Engineer

ShifaMed•Los Gatos, CA

56d•$170,000 - $200,000

About The Position

Our Principal Quality Engineer will establish quality practices and drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the process, design and development in early stages. As a key member of the team, you will create quality practices to current regulations and standards, and drive all aspects of design control. This position also represents an opportunity to influence the design selection, optimization, specifications, and test development and enable patient safety, quality and reliability in medical device software. This position will play an active role in developing quality management system and ensure QMS compliance adherence.

Requirements

B.S. or higher in Biomedical, Electrical, or Software (CQE preferred).
10+ years in quality engineering within the medical device industry, including electromechanical products and SaMD/SiMD.
Strong knowledge of Design Controls, Risk Management, and Software Verification & Validation.
Proficient in ISO 13485, FDA QSR, EU MDR, and software lifecycle standards (ISO 62304).
Experience with supplier quality, CAPA, nonconforming materials, and process improvement.
Exposure to human factors, usability engineering, labeling, and electronics reliability.
Ability to travel to support project objectives

Responsibilities

Develop and implement software quality plans, procedures, and policies to ensure adherence to quality standards.
Establish quality standards in procedures and work environments (i.e. bug tickets, threat modeling, cybersecurity).
Drive design controls deliverables, including but not limited to DHF, software requirements specifications, design / software verification and validation documentation and risk management documentation.
Develop risk management files and associated deliverables, such as FMEA and security risk management.
Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485, and ensure compliance to these regulations.
Prepare technical documentation, including but not limited to software design requirements, test methods, protocols, and reports, to support design control activities and regulatory submissions.
Provide guidance on applicable standards and regulations, and enable implementation of those into designs.
Review design control documentation, including but not limited to, requirements, specifications, test methods, protocols and reports.
Develop quality inspection methods and processes in manufacturing and design.
Qualify and maintain the suppliers per the supplier management process.
Lead Nonconforming Materials Report (NCMR) investigation and identify appropriate corrective actions.
Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
Provide support and lead sections of audits by outside agencies.