[ref. a52358618] Senior Software Quality Assurance Engineer - Canton, MA - Canton

About Our Client

This organization is an industry leading medical device company that are a global provider of scientific and analytical solutions. They have locations in both the US and the UK!

Job Description

Some of the responsibilities for the successful Senior Software Quality Assurance Engineer / Software QA Engineer will include:

• Lead the development, review, and execution of software quality assurance processes and procedures for projects within the organization
• Collaborate with teams in all areas of the organization to ensure software development and validation activities meet quality and compliance requirements
• Perform risk assessments and develop mitigation strategies for software-related issues
• Conduct software validation activities in accordance with regulatory standards (FDA, ISO 13485)
• Review and approve software documentation, including validation plans, protocols, and reports

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The suitable Senior Software Quality Assurance Engineer / Software QA Engineer will have the following experience:

• 3+ years experience as a Software Test / Software Quality Assurance Engineer
• Demonstrated commercial ownership in writing validation plans for a new product
• Experience writing the test suite for new product development in a regulated industry (medical device preferred but other regulated industries are also acceptable)
• A knowledge of requirements and how to work off requirements and successfully test a device
• Cyber Security experience through a recent FDA submission
• ISO 13485 experience
• CFR compliance experience
• Objective Performance Criteria (OPC) experience
• Great communication - both written and verbal

• Excellent benefits (Medical, Dental, Vision, 401k)
• Annual bonus on offer
• Flexibility to work hybrid when possible
• Generous PTO
• Excellent growth potential