Sr. Quality Engineer

Hello, I am reaching out as I’ve come across your resume profile and I was impressed with your credentials. I would like to share a role I am currently hiring for, a Sr Quality Engineer for a 06-month contract in Hopkins, MN with a with major medical device company. If you are not in the market yourself for a new opportunity, please let me know if you have any contacts in your professional network that might be interested. Job Descriptions: Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements. This role is accountable for determining changes or improvements needed to support the QA System and business driven objectives. In addition to these primary areas of focus, quality assurance will perform project work related to: Infrastructure (Hardware or Layered Software Installations), Application quality, Compliance initiatives, Validations, Internal / supplier audits, CAPA system investigation, confirmation, or verification. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for implementing and maintaining the effectiveness of the quality system. Accountable for ensuring that project documentation for the software development lifecycle (SDLC) is followed for quality and non-quality applications. Provides project management for validation or SDLC activities including: Client QA time estimates, provides software validation / QA guidance to clients and QA team, Organizing validation or SDLC material for library or electronic storage, Coordinate and / or lead validation review board meetings. Responsible for assessing risk and applying risk-based approach strategies without compromising compliance. Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators. Responsible for evaluating system (applications, layered software, & hardware) implementations or changes for impact on other systems. Perform inter- and extra- audits divisional audits against Abbott Polices, Procedures, Processes, Guidelines, etc. under the guidance of senior QA staff. Responsible for coordinating, facilitating, and reporting inspections or observations completed for or on CIT. Recommend modification to CIT quality and non-quality systems and drive changes through the approval process. Develop and maintain written policies and procedures related to the SDLC. Perform Quality Engineering function related to process improvements, metrics collection and analysis, and adherence to defined Abbott practices. Requirements: Associates Degree or higher and minimum of 5 years, to include experience in one of the following areas: Experience in a formal software development life cycle (5-9 years). Experience in regulated software environment. (2-3 years) Project Management in software experience (1-2 years) Thank you and I hope to hear from you soon. Regards, Kushagra Mohan I Recruitment Specialist 414-482-5732, Ext:7165 Kushagra.mohan@experis.com Experis CORE Who We Are – Experis As the leader in project solutions and professional talent resourcing for contract and permanent positions, Experis matches professionals to rewarding Finance, IT, and Engineering opportunities with industry leading organizations helping accelerate careers, while delivering excellent results for our client companies. Experis is part of ManpowerGroup, the world leader in innovative workforce solutions. Learn more at Experis is an Equal Opportunity Employer (EOE/AA) Ripple Media

Full Time

 

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