Quality Engineer (Service Quality)

Job Description Summary

Reporting to the Operations Manager, Service Quality, Worldwide Infusion Preparation and Delivery (WWIPD) function, the Associate will provide support and expertise in the daily running of Quality Management System (QMS), Service and Repair process, and Post Market Surveillance activities. Through proactive communication across organization, effective problem solving and active vigilance on applicable requirements, Associate drives compliance and effectiveness for assigned QMS processes. Associate is also expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined strategies and objectives.

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 Medication Management Solutions at BD

With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems, and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.

About the role

The Quality Engineer will provide support and expertise in the daily running of the quality management system (QMS), service and repair process, and post-market surveillance activities. Through proactive communication across the organization, effective problem solving and active vigilance on applicable requirements, the Associate drives compliance and effectiveness for assigned QMS processes. Associate is also expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined strategies and objectives.

Main responsibilities will include:

• Drives QMS and change control processes for Worldwide Infusion Preparation and Delivery (WIPD).
• Support the Post-Repair Complaint process, driving investigations and providing feedback.
• Conduct analysis of serviced products to identify root causes of failures.
• Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products.
• Preparation of QMS Metric reporting and Post Market Surveillance (PMS) activities relating to Service Quality.
• Support service systems updates and improvements, ensuring Quality and Regulatory requirements are met.
• Support Service and Repair related CAPA and SCAR activities across WWIPD.
• Generates and approves deviations from the standard service operations, including rework operations carried out by 3rd parties, etc.
• Supports the integration and establishment of QMS requirements for new businesses and facilities as required.
• Lead and support ongoing Quality Improvement projects and initiatives.
• Supports engineering and systems projects internationally by providing quality engineering and systems input.
• Perform other duties as assigned

About you

• Requires a minimum of a technical degree with a minimum of 2 years of relevant experience, or work experience of a minimum of 5 years within the medical device industry.
• A strong knowledge of worldwide applicable regulations for Quality Systems (EU MDR, ISO13485, 21CFR820 etc.).
• The ability to collect data, analyze situations and propose optimal process solutions to meet both Compliance and Business requirements.
• An individual in this role must have results oriented, organization and time management skills with a strong orientation on processes.
• Strong communication skills required to interact with colleagues and partners in a diverse international setting.
• A working knowledge on managing life cycle documents and records and understanding of change control and training process requirements.

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

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Primary Work Location

GBR Winnersh - Eskdale Road

Additional Locations

Work Shift