Title:  Incoming Quality Auditor

Job Summary

In this onsite role, you will support Incoming Quality functions and inspections for purchased components, raw materials, and finished goods to ensure that all received products meet quality standards and specification requirements.

Essential Duties and Responsibilities

• Coordinate the receipt, sampling, and inspection of incoming materials and goods.
• Perform visual, variable, and functional inspections/testing of incoming materials to verify adherence to specification requirements and enter results within the ERP system.
• Review supplier documentation, packaging, labels, and physical product against specifications and purchase requirements to ensure completeness and accuracy of orders.
• Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions.
• Determine product acceptability by performing various types of inspections and measurements utilizing varying equipment, such as light inspection booth, color spectrophotometer, FTIR, gages, etc.
• Create, utilize and maintain testing result forms.
• Provide assistance in the development of sampling plans and activities, as required.
• Cleaning and maintaining Incoming Quality lab equipment as defined in local procedures and/or instructions.
• Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system.
• Assist Quality management in the creation of procedures and conduct internal audits as required.
• Other duties as assigned.

Additional Responsibilities

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

Education

• High School Diploma or equivalent required..

Work Experience

• Minimum 2 years previous/related experience in Quality Assurance/Quality Control required 

Preferred Knowledge, Skills and Abilities

• Previous experience in Quality Assurance/Quality Control preferred.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers or bags of product, using hands and fingers to touch or feel materials or products, and listening for audible tones of equipment.  This requires that the individual have normal hearing ability.  The employee must be able to maintain concentration and visual acuity on tasks for extended periods.
• The employee must occasionally lift and/or move up to 35 pounds. 
• The employee must perform visual inspection of product, color standards, raw materials and graphics.  Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification. Required to work 40 hours a week and some overtime.
• Must be familiar and proficient with computers and various software programs such as: Microsoft Word, Microsoft Excel, Master Control, and SAP.

Shift

Monday - Friday - 1st Shift