Quality Engineer
C. R. Bard - Humacao Municipio, PR

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Summary of Position with General Responsibilities:

The Quality Engineer is responsible for assisting the QA Operations Support Mgr. in the development, implementation and operation of the Quality System for the economic control of the quality of raw materials, in process and finished products.
The scope of the position encompasses, but is not limited to development and audit of inspection criteria and methods, technical and statistical investigation on quality problems and complaints, product and process validation, vendor audits.

Essential 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 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

•Performs and approves IQ’s, OQ’s and PQ’s of manufacturing, packaging, test and inspection equipments and/or process performance validations

•Conducts audits to assure compliance to BARD 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 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 a variety of functional groups, including Design Engineering, Manufacturing Engineering, Purchasing, The Financial Department, and all production and inspection personnel in the facility. Also, evaluates 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
  • Executes other duties assigned by supervisor

Basic Qualifications:

•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 persons 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

Additional Desirable Qualifications Skills and Knowledge:

•Bachelors Degree in Engineering

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

Education and/or Experience:

•Bachelors Degree in Engineering

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

Physical Demands:
  • Hours of operation are flexible and vary depending on job requirements. Typical work week is 40 hours with additional/variable hours for specific work periods and projects. Specific work days and hours are flexible and may change with advance notice.
  • The nature of the work requires exposure to chemicals, noise. Exposure to machinery and non-ionizing radiation

About this company
9 reviews
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...