PierianDx Hiring for Senior Qa Engineer (verification & Validation) at Pune, Maharashtra, India Full Time

Job Description

Senior QA Engineer
Location: Pune, India
Total years of experience- 5 to 8 years
Job Summary:
Currently seeking talented and motivated Verification and Validation Engineer. The engineer conducts software development Verification and Validation lifecycle, including authoring, reviewing, managing deviations, executing and sign off verification & validation reports, and any ancillary documentation that supports the project. The position Interprets requirements and specifications to develop, test cases and test documentation, participate Verification and Validation plans, executes manual and automated tests and protocols; and reports, tracks and closes issues, and evaluates status of testing.
The Verification & Validation engineer actively owns documentation (e.g. requirements, design, code review reports, unit and integration test cases, unit and integration test reports, static analysis reports, etc.) and performs functional-level testing, including both Device software, Web applications, databases, Infrastructure.
Required Skills and experience:

• Experience in software verification and validation, in preferably in the medical device or pharmaceutical industry.
• Knowledge of latest automation tools and provide insights to minimize execution times.
• Excellent technical documentation writing and organizational skills.
• Understanding of FDA Quality System Regulation, IEC 63205 Guidelines and ISO 13485.
• Medical device development knowledge, including Verification and Validation activities, Verification and Validation protocol development, creating test plans, test procedures and test reports.
• Knowledge of software engineering practices, SQA process and methodologies.
• Soft skills: Communication, fast learner, proactive, constructive attitude

Desired Skills and Experience:

• FDA, Medical Devices, Validation, Automation Testing

Responsibilities:

• Proactive ownership of execution of Verification & Validation activities.
• Support QMS in various SOP’s for Verification and Validation activities.
• Perform software verification lifecycle, including author, review, execute and approve verification reports, manage deviations, and any ancillary documentation that supports the project.
• Execute manual and automated tests, and report, track, close issues, perform risk assessment on issues and link test cases/steps to requirements.
• Analyze overall Verification and Validation results and generate Verification and Validation Summary Report.
• Work with the project team to help resolve software issues.
• Interpret requirements and specifications to develop test procedures, test cases and test documentation and execution.
• Perform qualification of tools used to create and test medical devices.
• Modify/update test protocols, test procedures and test cases based on requirement changes; perform regression analysis and regression testing.

About PierianDx:
Every year millions of people bet their lives on precision medicine. PierianDx is on a mission to make sure that bet pays off. At PierianDx we empower progressive health institutions and diagnostic laboratories to build world-class precision medicine programs. Our industry-leading molecular genomics technologies and expertise deliver the most integrated, trusted, and collaborative approach across the clinical care spectrum. From genomic sequencing and biomedical informatics in the laboratory to reporting and decision support at the patient’s bedside, we drive the adoption of genomics in clinical care and accelerate the fight against cancer and other diseases. For more information, visit www.pieriandx.com or @PierianDx on Twitter.

• Outstanding career development and learning opportunities
• Competitive compensation depending on experience and skill
• Friendly team and enjoyable working environment
• Flexible working schedule
• Corporate and social events