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Company

Original Job Post

Truvian · 3 days ago

Senior/Staff Software Quality Engineer

San Diego, CA

Full-time

Onsite

Senior Level

$120K/yr - $135K/yr

5+ years exp

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Responsibilities

Contribute to design control outputs, including SRS and Quality Assurance deliverables, to ensure full and accurate coverage for verification/validation, release, and FDA submission.

Ensure SQA team compliance with policies, procedures, and regulations through regular reviews and feedback.

Provide quality oversight and guidance to project teams by ensuring that Software Quality Engineering principles are utilized to develop and enhance robust, safe, and effective products.

Build working relationships with the Quality/Regulatory team to drive effective compliance with quality and regulatory requirements and needs.

Develop and provide training to company personnel and external resources for the software development and verification/validation program.

Create, review, and execute software-related deliverables per the Software Development Life Cycle, such as Requirements, Development/V&V Plans, Risk and Hazard Analysis, Test Plans/Protocols/Reports, Design Specifications, Configuration Management, etc.

Provide quality oversight and guidance around risk management deliverables.

Ensure software-related deliverables are integrated with higher-level system and component quality deliverables.

Follow and enhance software event/defect tracking procedures.

Interface with external partners in V&V activities.

Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes.

Represent software quality assurance at project meetings and guide project and functional management.

Review, revise, and write instructions and procedures. Ensure quality and consistency in documentation and adherence to internal procedures, applicable standards, and regulatory requirements.

Work with cross-functional teams to collectively identify, analyze, estimate, and reduce risks to patient safety.

Create and/or review and approve change activities.

Participate in internal and external audits and respond to audit observations as needed.

Perform other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

IVD/Medical Devices software testingDesign controlsRisk managementFDA regulationsGMPIEEE 1012ISO 13485IEC 62304IEC 60601IEC 61010HIPAAQuality System RegulationsMedical Device DirectiveISO 14971FDA Pre-Market & Post-Market Cybersecurity GuidanceCybersecurity regulationsIMDRFANSI/UL 2900Software testing practicesTesting methodologiesTest Automation frameworksCybersecurity principlesComputer skillsStatistical analysisData analysisReport writingDetail follow-upMulti-functional teamContinuous improvementProblem-solving

Required

BS degree in Engineering (Electrical, Mechanical, Computer science, etc.) or equivalent Technical Field experience

5 or more years of experience in IVD/Medical Devices software testing

Extensive design controls and risk management experience

Knowledge of FDA and industry/international standards (including 21 CFR Part 11), GMP, IEEE 1012 and ISO 13485, IEC 62304, IEC 60601, IEC 61010, HIPAA

Knowledgeable of FDA 21 CFR Part 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485 and 14971 standards, FDA Pre-Market & Post-Market Cybersecurity Guidance, and international cybersecurity regulations/guidance such as IMDRF, ANSI/UL 2900

Experience in software testing practices, methodologies, and techniques, particularly in testing medical devices. IVD is a plus

Experience in Test Automation frameworks and processes

Understanding and application of basic cybersecurity principles

Advanced computer skills, including statistical/data analysis and report writing skills

Organizational, planning, and detail follow-up skills required

Strong analytical skills and effective problem-solving ability

Ability to work in a multi-functional team environment

Demonstrated ability to be flexible and resourceful

Ability to work independently, with minimal supervision

Utilize a constructively assertive approach that reaches out, speaks up, and drives continuous improvement

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Preferred

ASQ CSQE certification desired

Benefits

Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K)

Paid parental leave

Flexible PTO

Kombucha and cold brew on tap

Craft coffee

A variety of healthy snacks

On-site gym and virtual classes

Farm to table onsite restaurant including a 30% discount

Company

Truvian

Truvian is a transformational diagnostic company bringing lab-accurate results to the point-of-action where consumers engage healthcare providers to lead healthier lives.

Founded in 2015

San Diego, California, USA

51-200 employees

https://www.truvianhealth.com

H1B Sponsorship

Truvian has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2022 (2)