Quality Assurance Specialist ensuring compliance with quality standards in MedTech company. Collaborating with cross - functional teams and maintaining quality improvement processes.
About the role
- Staff Software Design Quality Assurance Engineer ensuring quality in software development and compliance at Caris Life Sciences. Collaborating with teams to improve patient outcomes through innovative medical solutions.
Responsibilities
- Authors (as needed) and ensures quality records are produced during software development, verification, validation, and maintenance activities for SiMD and SaMD products
- Reviews and approves various Design History File documents related to the software, including, requirements, design, development, architecture and integration, test protocols, verification, validation, trace matrix, risk management (including cybersecurity), and configuration management
- Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software Validation Planning documents in alignment with FDA QSR, 21 CFR Part 11, and GAMP5 regulation requirements
- Collaborates with regulatory partners as a software quality subject matter expert to support regulatory submissions
- Suggests design or test methods to achieve exceptional levels of product reliability, security, and quality
- Leads the cross-functional product development teams in performing risk assessments, defect assessments (FMEA), and cybersecurity risk analysis
- Able to work independently with minimal supervision with objectives given by Sr. Software Quality Engineering Director
- Also able to work with reporting software quality leader to support long-term software quality strategy for software medical products and computerized systems products
- Able to provide technical leadership and mentorship to software quality engineering peers
- Serves as the designated backup to the Sr. Software Quality Engineering Director, assuming leadership responsibilities during the leader’s absence to ensure operational continuity and decision-making coverage
- Participates in Supplier Qualification Audits of software suppliers that will be used to support the development of an Off-the-shelf (OTS) computerized system
- Partner with a lead auditor to ensure the supplier’s software development and validation practices comply with Caris’s Computer System Validation Process
- Leads process improvement initiatives as necessary, performing gap analysis and risk communication
- Software Quality SME for internal, external, and regulatory audits
- Performs complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management
- Can plan and coordinate own work according to higher-level project schedule demands
- Executes quality, and compliance activities within required timelines, ensuring documentation, validation, and other software release artifacts are completed on schedule
Requirements
- Bachelor’s degree in an engineering, scientific or related field with minimum 8+ years of relevant hands-on experience
- Project experience (preferably 5-7 years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices
- Strong knowledge of SDLC process and the application of ISO 13485, FDA QSR, 21 CFR Part 11, IEC 62304, GAMP5, SOX, and SOC2 requirements
- Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitHub
- Solid knowledge of agile/scrum SDLC methodology
- Experience in leading, coaching and mentoring software quality engineering peers
- Must possess communication, negotiation skills, and the ability to influence and guide team members
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Must have the ability to manage multiple tasks simultaneously with thoroughness
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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