Job Description Summary
As Complaint Handling Specialist you will be responsible for supporting and maintaining regulatory compliance for BD APM's worldwide quality systems, ensuring adherence to internal and external regulations, including ISO, GMP, and other relevant guidelines. This role is critical to maintaining the integrity of BD's processes and products, contributing to quality and patient safety.Job Description
Main responsibilities will include:
- Investigate complaints with the support of higher-level team members or managers
- Evaluate event to determine if it qualifies as a complaint
- Manage customer relationships and expectations during the course of complaint investigation and resolution process
- Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate
- Prepare and submit Vigilance reports to CA
- Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
- Collaborate in the management of CAPAs (Corrective and Preventive Actions), investigating root causes and ensuring effective implementation of actions.
- Manage QMS documentation, including the creation, review, and updating of procedures, work instructions, and other related documents.
About you
- University degree in Engineering, Science (Chemistry, Biology, Pharmacy), or related field
- Experience in complaint handling roles in the pharmaceutical, medical device or similar industries
- Excellent oral and written communication skills, both in Spanish and English
- Knowledge of ISO 9001, ISO 13485, GMP and other applicable regulations is a plus
Click on apply if this sounds like you!
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.
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Our vision for Advanced Patient Monitoring (APM) at BD
BD Advanced Patient Monitoring is a global leader in advanced monitoring solutions that expands BD's portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline. BD Advanced Patient Monitoring's technologies are often used simultaneously with the BD Alaris™ Infusion System in the operating room or intensive care units. The combination of BD's new advanced monitoring and existing infusion platforms enables future innovation opportunities for closed-loop hemodynamic monitoring and IV fluid and medication administration by integrating combined company data sets and interoperability capabilities.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
To learn more about BD visit:https://bd.com/careers
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Primary Work Location
ESP Valencia - PaternaAdditional Locations
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