Job Description Summary
The Senior Quality Assurance Engineer (Projects) provides quality assurance support and oversight in implementing and maintaining the Quality Management System in compliance with the requirements in the BD Quality Manual, BD SOPs, the Medical Device Regulation 2017/745, and ISO 13485. This position also provides Quality assurance support and oversight of projects for product development, process improvement, C2W, and Quality improvement.
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.
Want more jobs like this?
Get jobs in Bracknell, United Kingdom delivered to your inbox every week.
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.
About the role
The Senior Quality Assurance Engineer (Projects) provides quality assurance support and mentorship for implementing and maintaining the Quality Management System in alignment with the requirements in the BD Quality Manual, BD SOPs, the Medical Device Regulation 2017/745, and ISO 13485. This position also provides quality assurance support and mentorship for projects related to product development, process improvement, C2W, and quality enhancement.
Main responsibilities will include:
- Providing quality oversight of project documentation, including ownership of the change control associated with the project.
- Providing QA support for product development of infusions systems and accessory devices by reviewing and approving technical documentation such as test protocols, validation protocols and reports including quality support during design reviews.
- Quality documentation required by the project to comply with the BD QMS.
- Reporting and escalation through relevant channels of any impacts to product quality.
- Providing quality support for the creation and management of Buy Specifications.
- Supports the introduction and compliance of BD global initiatives to enhance, maintain or manage the QMS.
- Ensuring all project activities align with relevant legal, environmental, and safety regulations and internal QMS requirements.
- Collaborating with project teams and other functions, such as Regulatory, R&D, Procurement, Quality Engineering and Medical Affairs. Fostering effective teamwork to identify potential design improvements for more efficient production and product quality.
- Lead continuous improvement, simplification and business process enhancements projects by applying relevant methods (eg. DMAIC).
- Support and participate in the change order processes including as necessary, creation of changes, participation in reviews and approvals.
- Gather and analyze key performance indicators, find improvement areas, and lead improvement projects.
- Coordinate with supplier quality, ensuring supplier qualification activities for new and existing suppliers or sub-contractors. Provide support to supplier quality, where applicable, for these activities.
About you
- Relevant Engineering Degree ( Engineering, Biomedical Engineering).
- 5+ years' experience in Quality assurance, Design assurance or Quality engineering role, preferably in the Medical Device Industry.
- Experience within a highly regulated industry and relevant ISO standards.
- Experience leading project teams or leading workstreams (formal project management experience is a plus but not required).
- Experience in Process Validation and test method validation is preferred.
- Strong organizational and Project Management skills.
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
Required Skills
Computer Literacy, DMAIC Process Improvement, ISO Standard, Problem Solving Tools, Project Management, QA Project Management, Quality Engineering, Quality Management System (QMS) Compliance, Quality Support
Optional Skills
Lean Six Sigma (LSS), Lean Six Sigma Principles, Risk Management, Six Sigma Techniques, Validation Processes
.
Primary Work Location
GBR Winnersh - Eskdale Road
Additional Locations
Work Shift