Job Description Summary

The Quality Engineer reports to the Quality Manager at the Salamanca Site. This position will perform a variety of quality assurance activities to ensure successful completion of projects or programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and sustaining of medical devices. Supports development and successful implementation of quality systems and procedures. Supports maintenance and expansion of QMS as required.

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!

About the role

The Quality Engineer reports to the Quality Manager at the Salamanca Site. This position will perform a variety of quality assurance activities to ensure successful completion of projects or programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and sustaining of medical devices. Supports development and successful implementation of quality systems and procedures. Supports maintenance and expansion of QMS as required.

Main responsibilities will include:

• Qualify and validate QMS electronic Systems
• Qualify and validate manufacturing processes and tooling/equipment.
• Ensure that validation and project files are complete and auditable
• Ensure manufacturing processes are planned and implemented according to the applicable Quality principles, policies and procedures.
• Support other processes or activities related to risk management, design control, products sustainability, post market including write detailed technical and or quality plans and reports.
• Investigate and collaborate with multi-functional teams to resolve quality issues via CAPA and NC management and implement corrective actions
• Collaborate with multi-functional teams and other leads or sites to establish, implement or enhance QMS best practices and to ensure the highest level of quality is being applied and achieved.
• Participates in regulatory compliance audits and inspections along with support of any corrective actions resulting from audits.

About you

• Bachelor’s Degree required, preferably in Science or Engineering
• Minimum of 2-3 years of experience in QA or Operations areas
• Applied knowledge and understanding of the quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR/IVDR)
• Experience in writing and performing equipment and software validation protocols
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
• Proficiency English is required

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