Published: January 12, 2018
- Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards at the most economic level.
- Performs Quality Engineering activities to support product transfers from pilots and acquisition. Also provides operator training, validation of process lines, development and execution of protocols for validation.
- Provides support and assures cGMP’s compliance in product and process validations and product and process transfers.
- Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendation in a timely manner.
- Performs and approves IQ’s, OQ’s and PQ’s of manufacturing, packaging, test and inspection equipment’s and/or process performance validations.
- Conducts audits to assure compliance to Company procedures and specifications, as well as to regulatory requirements.
- Plays a key role in ensuring that the Corporation and customer’s quality requirements are met on assigned products, programs, areas and functions. Accordingly, participates in the review of all design, manufacturing, purchasing and test documentation to ensure that those requirements are fulfilled. This includes review of design drawings, operation documents, process procedures, test procedures, inspection analysis, vendor quality manuals and customer and military specifications.
- Provides technical and quality support so suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field.
- Reviews quality trends and plans overall defect reduction programs associated with his or her assigned products or program. Such trend information is available from formal sources, such as the quality reports and informally through frequent interaction with Supervisors, Inspectors and Production personnel.
- Interacts with representatives from a variety of functional groups, including Design Engineering, Manufacturing Engineering, Purchasing, The Financial Department and all production and inspection personnel in the facility. Also, shall evaluate customer complaints to identify any failure trends. This may require frequent interface with Division Field Assurance Department and suppliers on quality engineering issues.
- Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures, etc. and approves as appropriate to ensure product quality.
- Improves systems, monitors performance, and identify skills, training and capabilities needed.
- Monitors inspection and test results and initiate corrective actions to maintain acceptable levels
- Participates in budget preparation control expenses within the approved plan and participates in Cost Reduction Programs.
- Assures is trained before performing any task
- Uses the required clothes, personal and security protective equipment according to the requirements of its operation
- Complies with the cGMP’s, Quality Standards and established policies and/or procedures.
- Performs other duties as assigned
- Bachelor’s Degree in Engineering
- Three (3) or more years’ experience in the quality control and/or validation field.
- Must perform statistical analysis and have the ability to analyze data and communicate effectively in order to solve problems where past experience cannot necessarily be drawn upon
- Must be able to interact with different kinds of people in a harmonious manner, being cognizant of basic corporate, divisional and department goals
- Must have computer programming and software applications knowledge
- Must be bilingual (English and Spanish) and must have good communication skills both oral and written
- Team work oriented
- Willing to travel