Project Quality Engineer
Il y a 5 mois
**Job Description Summary**: Reporting into the Design Assurance organization, you act as an extended team member representing WW Quality on new product development projects and/or a team member for life cycle management/sustaining engineering projects.
You plan and deliver Quality Engineering activities to secure milestone/commitment achievement. You set priorities for self and contribute to team planning. You are as well responsible for 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.
**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
**Main responsibilities**:
- Evaluate customer requirements
- Initiate product development notification (ACR) and generate quality answer
- Develop quality plans (for GPDS projects)
- Lead risk management activities (PRM)
- Ensure design control elements are satisfied (DDP/CH, DIS, DOS, VEP, VER, VAP, VAR, DR, DHF)
- Ensure process validation activities are completed. Write worldwide validation plans as per project charter. Review local validation plans if applicable.
- Ensuring supplier qualification plans have been defined and performed in project scope
- Evaluate and validate test methods used in project activities
- Define control strategy for new product and update existing one (including long term verification)
- Release product under development
**Profile**
- Typically requires an **Engineer/ master’s degree in Quality management or Science****:
- Minimum of **3**-5** years’ relevant experience** like 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**:
- Knowledge of design control principles and related disciplines
- Understanding of statistical methods for Quality Assurance
- Knowledge of the six-sigma process methodology
- 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
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.
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
**Additional Locations**:
**Work Shift**:
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