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Position 2516
Senior Quality Engineer (Process Validation)

We are searching for a Senior Quality Engineer to help with the establishment and execution of software development process validation (non-product) to support a medical device company.

In this role you will work with software engineers to ensure that those tools and activities that support software development, such as defect tracking and customer complaint applications, are and remain compliant with FDA regulations for medical devices.

Ann Arbor, MI

Depending upon your skills and experience, this role has a target compensation of between $76K and $103K plus a 10% annual bonus

Bachelors degree in an engineering discipline (Computer Science, EE, etc.)

  • Minimum of six years of experience in software development and/or systems validation in a regulated environment
  • Strong understanding of software process validation as mandated by 21 CFR Part 11
  • Experience in one or more of the following system types: process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, quality systems
  • Excellent communication skills, both written and verbal. In this role you will spend a substantial portion of your day interacting with engineers to capture information from them which must be incorporated into documentation
  • While it is important that you are able to voice your opinion and stand up for what you know is right, it is equally important that you have a strong collaborative spirit and a willingness to offer and listen to alternatives to your ideas

  • You will work with enterprise systems like Etq, TLC, JDE, so any experience with these would be beneficial

  • This position is responsible for implementing best practices and company policies for software quality assurance (specifically for non-product applications that support our client's product development).
  • The role will include, but is not limited to: (1) planning and executing System Development Life Cycle activities per the established Quality Management System methodologies, (2) reviewing and approving various Software Development Life Cycle deliverables, change control, and resulting Objective Evidence to ensure adherence to the established company policies and regulatory requirements, and (3) working with stakeholders and members of designated project teams to ensure that computerized systems that are used in support of regulated activities and/or business processes, work as intended.

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