Published: October 2, 2018
- 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 assure 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 on quality problems, reporting the results and recommendation in a timely manner.
- Perform and review 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 to ensure requirements are fulfilled. This includes review 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 product returned from the field.
- Reviews quality trends and planning of 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 different groups, including Manufacturing Engineering, Purchasing, Financial Department and all production and inspection personnel in the facility. Also, evaluates customer complaints to identify any failure trends.
- Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures, etc. 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 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.
- Executes other duties assigned by supervisor.
- Must be thoroughly knowledgeable on CGMP’s, ISO 9000, OSHA and familiar with other regulatory requirements applicable to a medical device manufacturing operation
- 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 departmental goals.
- Must have computer programming and software applications knowledge
- Willing to travel
- Must be bilingual (English/Spanish) and must have good communication skills both oral and written
- Team work oriented
- 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.