The primary purpose of this position is to provide support and assistance to the Quality Assurance Manager by providing guidance, support,
training and direction to all employees within the Change Control Department. Also responsible for maintenance & implementation of electronic change control system(s). Manages day-to-day operations and provides leadership and direction to the functional team.
- Provide support, direction, training and guidance to all personnel within the Change Control Department.
- Provides support for the review of change order and all associated documentation to assess for accuracy and completeness.
- Assist change order initiators by providing guidance and training on the completion of change orders and associated documentation.
- As specified by change order, ensure change control creates or revises production, QC, packaging, equipment specifications and/or procedures, and QMS documents/forms.
- Provide assistance to Change Analysts with routing, distribution and maintenance of change orders and controlled documentation.
- Maintain & implement electronic change control system(s).
- Work with global functional team(s) on enhancements and/or implementation of electronic systems.
- Foster and maintain a workplace culture respectful and supportive of individual differences.
- Perform other duties as necessary.
- 4 year college degree in a technical discipline or equivalent experience
- Specialized training; including experience with Word processing, spreadsheet development and database software applications.
- Awareness of FDA’s QSR, ISO13485, Medical Device Directive (MDD) and Medical Device Single Audit Program (MDSAP).
- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
- Work is performed in a normal working environment with the majority of the day spent sitting and moving around various Departments.
- Work is performed in a normal working office and remote office environment.
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.