Duration – 5 Months+ (Possible Extension)
· Provides support for the Quality System during corporate audits, actively participate in department activities and Perform audits of operations areas to confirm compliance with controlled procedures, as required
· Reviews and updates inspection plans as needed. Write DCO’s (Engineering Change Requests) to update as required. Assist Operations personnel in maintenance and updating of other Device Master Record documentation.
· Writes and processes Material Reject Reports, as necessary, and manage inventory that is on hold for quality inspection.
· Completes archival activities for device history records for lots inspected.
· Completes all required quality inspections following inspection instructions and/or product drawings. Use department databases to track and manage inspection workload and rejected products. Effectively follow SOPs, policies, and ISO/QSR requirements.
Experience:
· Minimum 1 year experience in Quality Inspection (or minimum 2 years in a manufacturing environment where responsible for measurement of products) and preferably in an FDA regulated environment.
· Ability to interpret instructions and drawings to effectively inspect product. Working knowledge of GD&T preferred.
· Ability to utilize multiple gauges and measurement tools for inspection of manufactured components and assemblies.
· Use of math skills relative to physical measurement of product (calculations involving basic functions and some geometry/trigonometry in English and metric units).
· Knowledge of ISO, FDA and QSR concepts and guidelines preferred.
· Excellent communication and organizational skills.
· Outstanding attention to detail.
· Ability to work with others in a positive and collaborative manner.
· Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
· Knowledge of various MS Office applications such as: Word, Excel, and Access.