Job Functions:

• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards at the most economic level

• Investigates product complaints and directs the activities required to ensure the timely implementation and documentation of corrective action

• Provides support and assures cGMP compliance in product and process validations and product and process transfers

• Monitors quality trends and conducts technical and statistical investigations into quality problems, reporting the results and recommendations in a timely manner

• Performs and review IQ’s, OQ’s and PQs of manufacturing, packaging, test, and inspection equipment and/or process performance validations.

• Conducts audits to ensure compliance with BD procedures and specifications, as well as 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 to ensure requirements are fulfilled. This includes reviewing operation documents, process procedures, test procedures, inspection analysis, Vendor Quality Manuals, and customer and military specifications

• Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of products returned from the field

• Reviews trends and planning of overall defect reduction programs associated with their 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 different groups, including Manufacturing Engineering, Purchasing, Financial Department, and all production and inspection personnel in the facility. Also, evaluate customer complaints to identify any failure trends. This may require frequent communication 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

• Assures are trained before performing any task

• Uses the required clothes, personal and security protective equipment according to the requirements of its operation

• Stays in sync with the cGMP’s, Quality Standards, and established policies and/or procedures

• Performs other duties assigned by supervisor.

Basic Qualifications:

• Must be thoroughly knowledgeable of CGMP's, ISO 9000, OSHA and familiar with other Regulatory Requirements applicable to a medical device manufacturing operation

• Must perform statistical analysis and can analyze data and communicate effectively to solve problems where experience cannot necessarily be drawn upon

• Must be able to interact with diverse kinds of people in a harmonious manner, being cognizant of basic corporate, divisional and departmental goals

Skills and Knowledge:

• Must have computer programming and software applications knowledge

• Teamwork oriented

• Must be bilingual (English/ Spanish) and must have effective communication skills both oral and written

Education and Experience:

• Bachelor's Degree in Engineering

• Three (3) or more years' experience in the quality control and/or validation field, in a Medical Device manufacturing facility.