Worldwide Project Quality Engineer

**Job Description Summary**: The Project Quality Engineer is responsible to ensure that all aspects of the product/process development cycle have been addressed.

You will work in multifunctional Project Teams as Quality Core Team Member. You will act as well as WorldWide Quality referent in Clusters.

You will support new product/process development and product/process maintenance thru the use of the Quality Engineering skills. You take responsibility for all Quality Management activities during the four steps of a project
- Definition phase
- Development phase
- Qualification phase
- Launch phase

**Excited to grow your career?**:
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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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

BD Pharm System provides industry-leading needle technologies, prefillable syringes, safety and shielding systems, and self-injection systems for pharmaceutical and biotech companies across the globe.

Reporting into the Design Assurance organization, the WW Quality Engineer is an extended team member representing quality on new product development projects and/or a team member for life cycle management/sustaining engineering projects.
- Planning and delivering Quality Engineering activities to secure breakthrough/commitment achievement. Setting priorities for self and contribute to team planning.
- Combining design control expertise, problem-solving approaches and analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to risk management, process validation and control strategies.
- In addition, this position plays 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.

**Missions**

Provide Quality Engineering support to assigned R&D or WorldWide Operations projects:

- Evaluate customer requirements and applicable quality standards
- Ensure design control activities are satisfied
- Lead product related risk management activities
- Initiate change control submission and generate quality answer with the support of R&D and Engineering
- Ensure Worldwide Validation plan related to the product/process design is established and process validation activities are completed
- Ensure supplier qualification plans have been defined and completed
- Ensure appropriated robustness of test methods used in project activities (test method validation or equivalency when used in different sites (Plant, supplier )
- Define or update the product & process WW control strategy
- Release product under development
- Ensures quality conduct of project, including design, data summary, interpretation and report generation
- Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.

**Profile**
- ** Engineer/ Master’s degree in Quality management or Science****:

- Proven** experience** in high volume and regulated industrial environment
- Healthcare/Pharmaceutical/ Biologics/Medical Devices experience is a plus
- Thorough understanding of industry regulations/standards**: ISO 13485, QSR, GMP**:

- Understanding of statistical methods for Quality Assurance
- Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
- Knowledge and experience in manufacturing
- Good written and oral communication skills including in** English** language

In this position, you can regularly work in home office.

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, mil