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