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Akura Medical · 5 hours ago

Staff/Principal Quality Engineer (Software)

Los Gatos, CA

Full-time

Onsite

Lead/Staff

$150K/yr - $200K/yr

8+ years exp

Akura Medical is a Shifamed Portfolio Company focused on providing innovative solutions for venous thromboembolism. The Staff/Principal Quality Engineer (Software) will establish quality practices and ensure compliance in design and development, driving quality management systems and influencing design selection and test development in medical device software.

Health CareMedical

Hiring Manager

Cole Carnahan

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

Qualification

Quality EngineeringDesign ControlsRisk ManagementSoftware Verification & ValidationISO 13485FDA QSREU MDRSoftware Lifecycle StandardsSupplier QualityCAPANonconforming MaterialsProcess ImprovementHuman FactorsUsability EngineeringLabelingElectronics Reliability