Project Quality Engineer

**Job Description Summary**: As worldwide project quality engineer, you will:

- Report into the Design Assurance organization, the WW Quality Engineering Engineer II is an extended team member representing WW Quality on new product development projects and/or a team member for life cycle management/sustaining engineering projects.
- Plan and deliver Quality Engineering activities to secure turning point/commitment achievement. You will set priorities for self and contribute to team planning.
- Combine 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

**Our vision for quality at BD**:
In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.

**Main responsibilities will include**:

- Provide Quality Engineering support to assigned R&D or WW 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 performed
- Ensure appropriated adaptability 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.
- Liaise with Manufacturing Plants and SMO
- Provide Quality Engineering support to internal organizations, regulatory body and customer (ex: audits, requests )
- Continuous learning and improvement: Actively seeks training to improve skills. Ensures technical lessons are reviewed, learned, and disseminated. Supports continuous improvement of current products and practices to support the business improving quality and customer experience
- Ensure product compliance and implementation of PS global procedures and standards for assigned Quality Engineering activities

**About you**:

- Engineer/ master’s degree in Quality management or Science with a minimum of 2 years’ proven experience like high volume and regulated industrial environment
- Healthcare/Pharmaceutical/ Biologics/Medical Devices experience is a plus
- Good written and oral communication skills including in English language
- Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
- Knowledge of design control principles.
- Good understanding of statistical methods for Quality Assurance
- General working knowledge of the six-sigma process methodology
- Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
- Knowledge