Job Description Summary
The Quality Systems Specialist is responsible for supporting the continued development, improvement, and implementation of Quality Systems. This role actively participates in providing quality guidance and supports project and quality teams in continuous improvement initiatives.
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.
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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 amaker of possiblewith 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
Acts as a Subject Matter Expert in one or more areas. Supports the plant in identification and resolution of quality and/or compliance issues assuring compliance with IVDR, FDA regulations, ISO standards, corporate directives, and company strategies.
Main responsibilities will include:
- Collect, interpret, and analyze data, presenting findings orally or in writing. Understand published Quality System and Regulatory agency requirements, leveraging best practices. Make recommendations for project direction, including alternative solutions.
- Independently resolve and develop approaches to solutions, working autonomously within defined parameters with minimal supervision required.
- Develop, document, coordinate, and maintain Quality Systems to ensure conformance with regulatory requirements and company policies.
- Represent BD Drachten in cross-site/business unit teams related to Quality Systems, partnering with other quality professionals to address recurring issues identified throughout the organization.
- Manage Post Market Surveillance (PMS), including developing and maintaining PMS plans and reports, presenting results to stakeholders and senior leadership, ensuring follow-up and cross-functional collaboration to identify, confirm, and resolve PMS-identified product issues, and analyzing post-market data/metrics.
- Act as a Subject Matter Expert for complaint handling processes, conducting evaluations and analyses of customer complaints, coordinating investigation efforts, trending complaint data using statistical techniques, and identifying chronic complaint categories requiring investigation.
- Design and develop systems to transform raw data from enterprise databases into meaningful reports and dashboards. Manage, improve, and maintain Quality Systems data integrity (e.g., CAPA, complaints, audits, non-conformities, and other quality systems).
About you
- Bachelor's degree, preferably in engineering/life science and technology areas, with a minimum of 5 years of proven experience, or a master's degree with a minimum of 3 years of proven experience.
- Knowledge of EU and International regulations and standards that apply to the medical device industry, including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, MDD, EU MDR, etc.
- In-depth understanding of the application of quality systems to the medical device industry.
- Excellent English communication skills, both written and verbal.
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Effective meeting and presentation skills.
- Self-motivated and self-directed.
- Experience with Minitab or other statistical analysis platforms (preferred).
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
Primary Work Location
NLD Drachten - Marconilaan
Additional Locations
Work Shift