Job Description Summary
The Quality Technician reports to the Quality Manager in Salamanca. This position participates in activities supporting the design, manufacture, and release of clinical and research products that meet established specifications.
The role contributes to ensure product safety, product quality, QMS maintenance, the compliance with and application of quality standards, regulations and customer expectations.
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.
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--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 amaker of possiblewith 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 Technician you willparticipate in activities supporting the design, manufacture, and release of clinical and research products that meet established specifications. These activities to be supported 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.
The role gives to ensure product safety, product quality, QMS maintenance, the compliance with and application of quality standards, regulations and customer expectations.
-Main responsibilities will include:
- Assure that Quality Notifications (QN) are crafted, investigated, completed and closed in accordance to the established Standard Operating Procedures.
- Identify quality events and support investigations. Report quality issues to Quality Manager.
- Support other associates or departments in the accurate follow-up, documentation and completion of complaints, changes, CAPAs, corrections and records.
- Monitor, document and analyze Quality Metrics.
- Batch Record QA review
- Capture information for the Quality Management Reviews, for the preparation of reports and other department activities.
- Draft and update local SOPs or working instructions, analysis reports, plans and other quality documents.
- Support the Quality department in audits (external, internal and customer) and other investigations from regulatory agencies, Notifies Bodies, and customers.
- Act as a role model for Quality by the daily representation of all quality aspects and modeling and emphasizing quality in the workplace.
- Keep abreast of the basic requirements for compliance 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)
- 1 year 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 Good Manufacturing Practices (GMP)
- Upper intermediate 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
Required Skills
Optional Skills
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Primary Work Location
ESP Salamanca
Additional Locations
Work Shift