Primary Responsibilities
o Work collaboratively with manufacturing to collect and analyze quality data with the goal of bringing processes into control and reducing variation.
o Manage complaint response by marshalling the necessary members, assembling data to determine root cause, and implementing corrective actions necessary to eliminate the potential for similar complaints.
o Validate that standard work practices have been achieved between shifts by use of auditing and review of documentation.
o Update quality information management system to document customer complaints, non-conformances, audits, and corrective actions.
o Assist in the identification of potential risks in processes and products and participate in risk mitigation activities.
· Additional Responsibilities
o Train employees on new procedures, work instructions
o Coordinate/assist in resolution of nonconforming material
o Audit critical suppliers
o Perform statistical and graphical analysis of data
o Receive / reviews Supplier COA against customer specifications
o Generate Certificates of Conformance and Certificates of Analysis that meet customer requirements.
o Participate in management review and quality-related boards
o Maintain quality performance metrics as assigned
o Participate in maintenance of calibration system
o Participate in internal audits
· Education Requirements :
· Associates degree or equivalent required. Industry certificates (such as ASQ certificates) may substitute as equivalency upon evaluation.
· Work experience in a regulated industry such as medical and aerospace.
· Experience Requirements:
· Experience with MS Word, Excel, Access, PowerPoint and Visio
· Strong communication skills and attention to detail
· Experience using an electronic QMS and ERP
· Experience in methods and approaches to problem solving
· Strong grasp of manufacturing systems and processes
· Strong self-initiative and the ability to work independently to achieve results
Job Type: Full-time