Quality Assurance Engineer: Quality Assurance Engineer - Regulatory

We are currently looking for a Quality Assurance Engineer to support one of our software quality projects in Ashland, MA.  Communicating and interacting with the Senior Software Quality Assurance Manager, the Quality Assurance Engineer will work with Project Managers to maintain timelines and goals and assure regulatory standards are met within multiple projects.

 

Minimum requirements:

 

·         At least 3 - 5 years of project management experience and proven experience managing multiple projects simultaneously

·         At least 3 - 5 years of formal software testing and validation experience

·         At least 2 years of experience in FDA regulated software quality assurance and validation

·         A firm grasp of software auditing standards (ie: FDA, CMM/I, COBIT, AAMI, FAA)

·         Experience developing, establishing, validating, and maintaining standards for software quality methods, processes, and procedures which meet internal and external regulatory requirements

·         Proven working history and good understanding of various SDLC models and software testing methodologies and practices

·         At least 2 - 4 years of software quality assurance experience

·         Detail oriented with strong written and verbal communication and interpersonal skills

 

Pluses:

 

·         Knowledge of one or more regulated and / or certified software engineering environments

·         At least 2 years of software development experience

·         Knowledge of high level and detailed software design methods

·         SAP experience

Location: Natick, MA 01760
Category: Quality Assurance/Safety
Experience: 2+ to 5 Years
Career Level: Experienced (Non-Manager)
   
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