Engineer I

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Engineer responsible for providing engineering support to the manufacturing areas related to process and product activities, giving assistance on new product introduction, product and process changes, maintenance of validation program, investigations and promote continuous improvement of medical devices manufactured. 

Duties: 

• Provide technical support to Manufacturing engineering and quality areas.
• Participate on the evaluation of customer complaints, NCR Investigations, to provide technical support for process/product analysis for corrective and/or preventive actions during non-conformance investigations. 
• Support and maintain process or product validations and re-validation programs using local or divisional engineering resources.
• Generate validation protocols and reports for the qualification of process equipment or process changes.
• Develop and update standard operating procedures for new and/or existing processes and equipment. 
• Assist and support in the implementation of new product introductions, existing product design modifications, manufacturing improvements giving direct assistance on change process as change  control owner and/or action owner on local or divisional project. 
• Provide technical training support to manufacturing personnel.
• Be the plant facility representative at Divisional levels and interface with other plants and Divisional groups. 
• Coordinate and perform engineering project activities. 
• Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
• Observe confidentiality and data privacy rules at all times. 

• Bachelor Degree in Mechanical, Industrial, Electrical, or Chemical Engineering. 
• 1-2 years of experience in Engineering or related field required. 
• Ability to discuss normally encountered technical or project management issues, both verbally and in written form. 
• Ability to work as a collaborative team member.
• Ability to solve routine design, engineering problems with assistance. 
• Computer Applications to do process analysis. 
• Knowledge or problem solving and statistical techniques. 
• Bilingual (English & Spanish)  
• Some traveling required. 

All your information will be kept confidential according to EEO guidelines.