Software Validation Quality Engineer

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.

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)