Software Quality Engineer II

Labcorp is a leading healthcare company that provides a range of diagnostic and medical laboratory services to patients, healthcare providers, and biopharmaceutical companies. With annual revenue of over $10+ billion and more than 70,000 employees, Labcorp is a recognized leader in the healthcare industry.

Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products is now part of Labcorp.

PGDx is seeking a Software Quality Engineer, that will help fight cancer by ensuring software quality in complex in-vitro diagnostic products based on cutting edge, high-throughput DNA sequencing technologies. You will:

• Ensure that IVD software engineering and test outputs conform with PGDx software design controls.

• Review product designs and requirements to ensure that they are complete, unambiguous, verifiable, unique, and traceable.

• Ensure traceability between requirements, system test, design and risk control measures.

• Participate and document formal design reviews of software development plans, risk plans, software requirements specs, and test plans.

• Create test plans for new or updated software projects to determine if the software will perform accurately and reliably under both normal and error conditions.

• Perform product cybersecurity vulnerability evaluation.

• Review software development and validation related documents.

• Participate in software development and validation related meetings.

• Run software testing.

• Document software issues and follow up with software developers.

• 2+ years of quality, regulatory, design control, test/QA or software development experience.

• IVD regulatory experience under FDA 21 CFR Part 820 Quality System Regulations

• Risk/Safety analysis experience

• Ability to write and execute tests that expose flaws and weaknesses in software

• Experience with performance, stress, and scalability testing

• Effective communication skills

• Hard worker under tight schedule

• Organized and meticulous

• Eager to work in a startup environment

• Team spirit / ownership / can-do attitude

• Excellent verbal and written communication skills

• Bachelors or Masters in computer science, bioinformatics, or equivalent educational background

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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