Title: Staff Software Quality Engineer This position is based in our Campbell California offices. This position is onsite & fulltime
Why Telos Health At Telos Health an Imperative Care company we are developing novel roboticassisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke a disease that impacts close to a million people a year in the U.S. and 10 million worldwide. Not only is Telos changing the way stroke is treated but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease a disease in which one in four adults will face in their lifetime.
What Youll Do This position contributes to Quality Assurance development and maintenance of Imperative Care (Telos Health)s medical device software products in alignment with the Companys Quality Policy and Objectives. The role ensures compliance with applicable standards and regulations and delivering safe effective and highquality medical device software solutions.
Implement and maintain Quality Management System (QMS) processes procedures and techniques applicable to software development verification and validation.
Provide quality engineering support throughout all phases of the software development lifecycle including requirements development design reviews risk management V&V and design transfer.
Create review and approve software documentation to ensure compliance with internal processes and external standards (e.g. IEC 62304.
Actively participate in the software risk management process ensuring risks are appropriately identified analysed mitigated and documented.
Review software verification and validation (V&V) deliverables including test protocols test reports and traceability matrices ensuring they meet regulatory and internal quality standards.
Review cybersecurity documentation including threat assessments vulnerability analyses and mitigation plans to confirm compliance with applicable standards such as FDA guidance on cybersecurity for medical devices.
Prepare and maintain the software design history file (DHF) in alignment with FDA and international regulatory requirements.
Perform document control activities related to software deliverables ensuring accurate versioning and proper traceability.
Review design change orders (DCOs) involving software changes to ensure compliance with QMS and regulatory requirements.
Collect and report software quality metrics to monitor performance and identify opportunities for improvement.
Support projects with a sense of urgency consistent with corporate objectives.
May provide quality metric data to various functional groups within the organization.
What Youll Bring:
Implement and maintain Quality Management System (QMS) processes procedures and techniques applicable to software development verification and validation.
Provide quality engineering support throughout all phases of the software development lifecycle including requirements development design reviews risk management V&V and design transfer.
Create review and approve software documentation to ensure compliance with internal processes and external standards (e.g. IEC 62304.
Actively participate in the software risk management process ensuring risks are appropriately identified analysed mitigated and documented.
Review software verification and validation (V&V) deliverables including test protocols test reports and traceability matrices ensuring they meet regulatory and internal quality standards.
Review cybersecurity documentation including threat assessments vulnerability analyses and mitigation plans to confirm compliance with applicable standards such as FDA guidance on cybersecurity for medical devices.
Prepare and maintain the software design history file (DHF) in alignment with FDA and international regulatory requirements.
Perform document control activities related to software deliverables ensuring accurate versioning and proper traceability.
Review design change orders (DCOs) involving software changes to ensure compliance with QMS and regulatory requirements.
Collect and report software quality metrics to monitor performance and identify opportunities for improvement.
Support projects with a sense of urgency consistent with corporate objectives.
May provide quality metric data to various functional groups within the organization.
Employee Benefits include a stake in our collective success with stock options competitive salaries a 401k plan health benefits generous PTO and a parental leave program.
Salary Range: $160000 to 177000 annually Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position candidates work experience education/training key skills and internal equity as well as location market and business considerations when extending an offer. As part of our total rewards package Imperative Care offers comprehensive benefits including a 401k plan health benefits generous PTO a parental leave program and emotional health resources.
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