Job Description Summary

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.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Essential Job Functions:

• 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 equipments 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. Accordingly, participates in the review of all develop, 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 patterns and plans 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 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

• Aligns with the cGMP’s, Quality Standards and established policies and/or procedures

• •Performs other duties assigned by the 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, beingcognizant of basic corporate, divisional and departmental goals

• Must have computer programming and software applications knowledge

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

• Team work oriented

• Willing to travel.

Education and/or Experience:

• Bachelors Degree in Engineering

• Two (2) or more years experience in the quality control and/or validation field, in a Medical Device manufacturing facility.

Physical Demands:

See PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT table.

Work Environment:

• Hours of operation are flexible and vary depending on job requirements. Typical workweek 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

.

Primary Work Location

USA PR - Humacao

Additional Locations

Work Shift