The Design Assurance Specialist is responsible for providing support to Design Assurance Engineers and Management. Responsibilities include gathering documentation, reviewing and processing documents for Engineering Change Orders. The Design Assurance Specialist is expected to process updates in the Product Lifecycle Management (PLM) system for the Document Change Order (DCO) and Engineering Change Order (ECO) processes. The ability to effectively communicate, support, and work closely with management and team members is critical to the success of the position.
* Review elements of ECOs for completeness and accuracy * On behalf of Design Assurance, enter ECOs/DCOs into PLM * Update and review Design History Files log * Review status of software systems, tools and update Master Tool File * Maintain a positive work environment that is energizing and motivating * Collaborate with other departments as necessary (Doc Control, Regulatory, R & D, Systems, Lifecycle, PMs, Management) * Support internal and external audits, as required * Perform other duties as required
Education and Experience
* High School Diploma required and Associates Degree preferred.
Minimum of 3 years of experience in Administrative or Document Control position
* Experience with PLM systems (Arena preferred) * Effective verbal and written communication skills. * Experience in the medical device industry is strongly preferred * Strong organizational, attention to detail, and follow-up skills * Ability to work in a fast-paced environment, managing multiple priorities. * Ability to be open to change and fluidity within the needs of the business * Ability to achieve thoroughness and accuracy when accomplishing a task.
Physical Requirements (if applicable):
* Requires sitting and standing associated with a normal office environment. * Primary location will be the Insulet Acton office but occasional travel to Billerica office will also be required. * Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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