Senior Software Quality Assurance Engineer

Senior Software Quality Assurance Engineer - Permanent - Burlington, MA

Proclinical is on the lookout for a skilled Senior Software Quality Assurance Engineer. This is a permanent role located in Burlington, MA.

Primary Responsibilities:

The successful candidate will play a crucial role in product software development and validation activities within a medical device organization. Please note that eligibility to work in the US is a requirement for this role.

Skills & Requirements:

• Experience with New Product Development (NPD) of a software medical device, including completion of software validation for a regulatory submission.
• Knowledge of current regulatory industry standard requirements for administration of design control and validation elements of the Quality System in alignment with FDA 21 CFR Part 11 & Part 820, ISO 13485:2016, and IEC 62304:2006.
• Proven experience creating Software Development Life Cycle (SDLC) procedures.
• Ability to write and maintain requirements throughout a software development project.
• Experience with SDLC tool selection and validation.
• Familiarity with complex UI development and validation.
• Effective verbal and written communication skills.
• Strong organizational, problem-solving, and analytical skills.

The Senior Software Engineer will:

• Collaborate with the design team in software development activities, including planning, requirement development, software design output, change/configuration management, risk management, design reviews, and releases.
• Review and approve software product documentation.
• Oversee software validation testing activities and related documentation.
• Design test strategies and write test plans and cases.
• Validate automated tests and development/production tools.
• Log and verify bugs, and assist in root cause investigation and corrective action activities.

If you are having difficulty in applying or if you have any questions, please contact Victoria Kroon at +(1) 929-387-4315 or v.kroon@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.