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Job Description Summary

As Quality Specialist you will support the design, manufacture, and release of clinical and research products that meet established specifications. These activities include: environmental monitoring, validation, material disposition, in-process product disposition, finished goods disposition, data collection/trend analysis, quality auditing, Quality/Compliance Training, CAPA, complaint processing & investigation, quality record retention, quality documentation and change control process.

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.

--Why join us?--

A career at BD means learning and working 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.

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.

Become a maker of possible with us!

--Our vision for BD Biosciences at BD--

BD Biosciences (BDB) is a leading provider of high-quality flow cytometry and single-cell genomics solutions, scientific research and clinical laboratories. Here, we are leading the way by developing the best technologies that have the ability to look closer at the details of cells and diseases.

-About the role

As Quality Specialist you will support the design, manufacture, and release of clinical and research products that meet established specifications. These activities include: environmental monitoring, validation, material disposition, in-process product disposition, finished goods disposition, data collection/trend analysis, quality auditing, Quality/Compliance Training, CAPA, complaint processing & investigation, quality record retention, quality documentation and change control process.

-Main responsibilities will include:

• Monitor and control processes related to QMS elements including nonconformities, CAPA, complaints, document control, training, product post-market surveillance and follow-up, audits, change control, suppliers’ qualification, production and process control, design control

• Implement best quality practices, process improvements, plan and execute trainings

• Conduct investigations of quality events including cross functional work

• Monitor Quality Objectives

• Report quality metrics information

• Batch record QA review. Review product labeling, product design documents and others as needed (Quality review). Participate in the preparation and review of documents for regulatory bodies. Prepare plans, reports and other documents.

• Support the Quality department in audits (external, internal and customer) and other investigations from regulatory agencies, Notifies Bodies, and customers.

• Keep abreast of the basic requirements for compliance in own area of work and align with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.

• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

-About you

• Bachelor's degree or equivalent experience (preferred Life Sciences)

• 3 years relevant technical experience in a regulated industry or a combination of equivalent education and experience.

• Experience with ISO 13485 and/or ISO 9001 standards

• Knowledge of FDA 21 CFR 820 is expected

• High Level of English

Click on apply if this sounds like you!

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.

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

Primary Work Location

ESP Salamanca

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.