Insight Global is seeking a highly skilled and organized document review specialist to work along side Machine Operators and Quality Engineers through expansion of devices and products across the clients portfolio. This resource will be responsible but not limited to the following:
- Receiving documentation through a document management system
- Reviewing documents submitted by various team members (business analysts, testers, developers)
- Comparing documents against company SOPs, work instructions, and training procedures
- Checking technical documentation for accuracy and compliance
- Communicating with document submitters about potential issues or required changes
- Rejecting or approving documents in the electronic system
- Adding electronic signatures to approved documents
- Visiting manufacturing floors to understand system operations
- Tracking document lifecycle from initial submission to final approval
- Participating in project teams assigned to specific system qualifications
- Reviewing change control documents and proposed system modifications
The consultant will typically be assigned to a specific project team and work independently, with leadership available for high-level guidance. Project complexity can vary, with some systems taking weeks to qualify and others taking months.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
Human Resources Request Form. The EEOC "Know Your Rights" Poster is available
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- Medical device industry or Regulated experience required
- Understanding of automated batch manufacturing
- Technical background (engineering degree preferred - mechanical, biomedical, or computer science)
- Strong attention to detail
- Ability to understand software development lifecycle
- Knowledge of technical systems and how machines/software operate
- Familiarity with regulated manufacturing environments
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.