Job Description Summary
The Senior Global Quality Engineer is the core team member representing worldwide Quality on medium to high complexity new product development and/or life cycle management/sustaining engineering projects
You plan and lead Quality Engineering activities to secure turning point/dedication achievement often coordinating other extended quality SMEs (ex: Plant, Validation, Sterilization, Supplier). Sets priorities for self and contribute to team planning
You are responsible for combining design control expertise, problem-solving approaches and analytical skills to support projects/complex activities using strong quality engineering skills including but not limited to risk management, process validation and control strategies
In addition, this position will play an active role in the processes to ensure products meet customer/patient needs and quality standards consistently with both corporate and unit policies, while meeting all design control and other regulatory applicable requirements
Job Description
Responsibilities:
As the Quality Representative within the Project/Program Team:
* Translates the project strategy into an achievable quality plan covering all department activities, including risk management, process validation, and control strategies from raw materials to commercial product. You align the Platform/Segment with this strategic direction.
* Determine how to best apply allocated means/resources to meet objectives.
* Lead the execution of the quality plan to ensure project success:
* Understand the targeted market impact to define customer requirements and applicable quality standards.
* Ensure Design Control activities are properly followed.
* Lead product risk management activities.
* Initiate change requests and defines the quality response in close collaboration with R&D and Engineering.
* Ensure that a product and process design validation plan is established and that manufacturing process validation activities are accomplished "right the first time."
* Ensure supplier qualification strategies and plans are defined and completed.
* Ensure the robustness of test methods used in project activities is appropriate for the intended use of the results.
* Define or updates the product and process control strategy by integrating past findings and operational strategies.
* Approve the release of products under development.
* Ensure quality oversight of project management, including design definition, data synthesis, interpretation, and associated documentation.
* Identify issues that could impact the product or project and recommends appropriate actions.
* Lead quality reviews at key project achievements and at project closure.
* Contribute to the management of investigations and problem resolution in case of deviations from product requirements.
* Develop solutions to resolve complex problems, often requiring ingenuity and creativity.
* Review and approves changes to product and process specifications, test method validations, etc., on behalf of Quality Engineering.
Preferred Requirements:
* Deep understanding of ISO 13485, QSR, and GMP regulations. Strong command of Design Control principles and advanced knowledge of statistical quality assurance methods and Six Sigma methodology.
* Confirmed experience in quality systems, validation, FMEA, and risk management. Solid understanding of manufacturing processes and their quality implications.
* Able to independently lead multiple projects from design initiation to implementation and maintenance.
* Excellent written and verbal communication skills, including fluency in English.
* Demonstrates ownership and accountability for project success.
* Adaptable and committed in the face of change and uncertainty. Aligned with BD's values and quality culture. Strong understanding of the healthcare industry and related technologies.
Salary range for the role: €55 .000 to €65.000
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
Click on apply if this sounds like you
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.
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.
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