Job Description Summary

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.

Position Summary

Performs technical evaluation to products returned from customer as complaints. Prepare status reports of complaints and ensure completion of assessment according to requirements. Perform CAPA and nonconformance investigations. Prepare quality metrics, presentations, and lead meetings. Perform gap assessments of corporate standards and support related activities (ie. management the receipt of Corporate Standards, route for evaluation and ensure their implementation, as applicable). Participate in external audit readiness activities. Provide and support the GMP’s Training as required. Perform Data Management Audits (DMAs) and internal audits.

Responsibilities

• Manages the corporate standards release notifications, including maintenance of Logbook, assigning responsible personnel to perform gap assessments, routing the documents, and monitoring the implementation.

• Performs gap assessments of corporate standards impacting quality procedures.

• Prepares change requests to update procedures, making recommendations for improvement.

• Participates in the readiness activities and supports audits.

• Performs internal audits and data management audits as required,

• Provides training and supports all training activities (TONE, Annual Training, among others) under the quality system team.

• Prepares metrics reports and presentations. Lead meetings as required.

• Prepares, retrieves, and archives data/reports as required by quality management per company policies.

• Performs technical evaluation to products returned from customer as complaints, including verification of manufacturing history, to determine failure cause. Input data to the computerized complaints system and prepares trending and status reports.

• Follows the cGMP’s, Quality Standards, and established policies and/or procedures.

• Supports activities of the Quality Systems department as required.

• Assists on ensuring the facility compliance with all regulatory requirements.

• Assures are trained before performing any task

• Performs other duties assigned by supervisor.

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

Minimum Requirements

• Bachelor’s Degree in Science or Engineering

• Three (3) to Five (5) years of experience in Medical Device or Pharmaceutical industry, in Quality Assurance field

Basic Requirements

• Knowledge in GMP’s (QSR’s), and ISO 13485 regulations

• Must have an ability to work alone as well as in teams

• Self-starter

• Detail oriented with the ability to prioritize and perform multiple tasks

• Ability to perform technical evaluations/investigations

• Proficient in MS Office programs (ie. Power Point, Excel, Word, Visio)

• Must be bilingual (English/ Spanish)

• Good communication skills, both oral and written

• Good technical writing skills

• Strong attention to details

• Excellent data collection and analysis skills

• Teamwork oriented

Additional Desirable Qualifications Skills and Knowledge:

• Knowledge in complaints database applications (Track wise)

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.

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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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/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.

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