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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.

Job Summary:

The Quality Labeling Engineer provides on-site technical support for labeling (for example system and artwork update implementation) and regulatory compliance projects (for example MDD / EU MDR related implementations). Possesses technical responsibility for interpreting, organizing, executing, coordinating, and carrying out assignments based on defined requirements and strategies.

**Job Responsibilities:** _(Primary Duties, Roles, and/or Authorities)_

+ Serves as point of contact between Division and site for packaging/labeling requirements updates.

+ Supports the development of component specification.

+ Coordinates with Planner/Buyer the purchase and delivery of new packaging components.

+ Maintains contact with Suppliers of Packaging Components as required.

+ Development and execution of Component Qualifications (including Protocols / Reports documentation).

+ Generates redlines to update SOPs, MPS, IPs, WIMs among other documents.

+ Generates change request (CRs) for the approval of the required documentation updates.

+ Close communication with stakeholders such as Manufacturing areas, Supply Chain, RA, Document Control and Division representatives.

+ Responsible to maintain tracking of assign tasks status and provide updates as required.

+ Complies with cGMP’s, Quality Standards, and established policies and procedures

+ Executes other duties assigned by his supervisor

+ 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

Education and Experience:

+ College degree in Engineering, or should be in the last semester of their College degree

+ Previous experience in the following fields is a plus:

+ Manufacturing

+ Component Qualifications

+ Demonstrated ability to plan and manage multiple projects

+ Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization.

Knowledge and Skills:

+ Working knowledge of US FDA and International regulations governing the medical device industry, i.e., QSR, GMP, MDR, and ISO 13485.

+ Knowledge of fundamental quality systems principles

+ Knowledge in Qualification / Validation (IQ/OQ/PQ), Packaging Validation and Labeling Verification

+ Demonstrated critical thinking skills and problem-solving skills.

+ Ability to deal effectively with all levels of management.

+ Excellent communication and technical writing skills in both English and Spanish

+ Computer Literate: Microsoft Office (Power Point, Word, Excel) among others

+ Teamwork oriented

+ Must have good independent judgment and a demonstrated ability to set priorities

+ Be able to maintain multiple ongoing tasks on a tight deadline and work at a fast pace

+ Ability to work in a cross-functional team environment, as well as the ability to function independently

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.

\#earlycareer

Required Skills

Optional Skills

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Primary Work Location

USA PR - Humacao

Additional Locations

Work Shift

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.