Software Validation Quality Engineer

huMannity Medtec; Santa Clarita (CA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

9/80 work schedule

26 long weekends annually

Job summary

A medical technology company in Santa Clarita is seeking a Software Validation Quality Engineer to join their Quality Assurance team. This role involves ensuring software systems meet compliance standards, executing validation protocols, and supporting process improvements within a collaborative environment. Ideal candidates should possess a Bachelor's degree and experience in the medical device industry, particularly with ISO 13485 and IEC 62304 standards.

Qualifications

• 3+ years of experience in the medical device industry required.
• Experience with ISO 13485:2016 and IEC 62304 is a must.
• Knowledge of FDA’s General Principles of Software Validation Guidance needed.

Responsibilities

• Identify software that needs qualification, verification, or validation.
• Execute and maintain software quality engineering methodologies.
• Work with R&D and engineering teams to complete software verification and validation processes.

Skills

Software validation methodologies

Risk management

Technical writing

Data analysis

Education

Bachelor’s degree

Tools

Test equipment

ISO 13485 standards

Job description

Base pay range

$110,000.00/yr - $140,000.00/yr

At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at their best every day, and take your career to the next level, apply today!

We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year!

We are looking for an experienced and highly motivated Software Validation Quality Engineer to join our Quality Assurance team and help us improve processes, increase efficiency, and maintain our ISO 13485 certification.

Position summary: The Software Validation Quality Engineer (SVQE) shall be responsible for system and software validation activities for electronic computer systems including performing risk management activities for quality system software (eQMS).

Summary of responsibilities:

• Responsible for identifying any software that needs to be qualified, verified, or validated, this includes but is not limited to computer electronic systems, off-the-shelf software, and systems software.
• Responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.
• Ensures software systems are developed, validated and maintained in compliance with regulatory requirements and business needs.
• Provide guidance and support to R&D engineers for Software Validation, Data Integrity, and Software Requirement Specifications.
• Work with R&D, Quality Engineering and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
• Participate in reviews for System and Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
• Create and execute or direct software validation protocols traceable to system/software requirements.
• Execute and support on-time completion of Software Validation Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports.
• Use test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data.
• Participates in designing, coding, testing, debugging, and configuring computer software.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS).

Education/Experience:

• Bachelor’s degree and 3+ years of practical experience in the medical device industry.
• Must have experience with ISO 13485:2016 and IEC 62304
• Knowledge of FDA’s General Principles of Software Validation Guidance
• Familiarity with standards such as GAMP5
• Risk management knowledge for the medical device industry (ISO 14971)

Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance and Engineering