BD (Becton, Dickinson and Company) Quality Engineer (On Site) in Puerto Rico
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Summary of Position:
The Quality Engineer is responsible for the 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 conducting and supporting audit of inspection criteria and methods, technical and statistical investigation on quality problems and complaints, product and process validation, vendor audits.
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 review IQ’s, OQ’s and PQ’s of manufacturing, packaging, test and inspection equipment and/or process performance validations
Conducts audits to assure compliance to BD 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 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. 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
Follows the cGMP’s, Quality Standards and established policies and/or procedures
Performs 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 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
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
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson, and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA PR - Humacao
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.