As a Quality Systems Specialist at BD, your primary responsibilities include performing Post Market Surveillance (PMS) activities, ensuring compliance with medical device regulations, and compiling PMS Plans and Reports. You'll work collaboratively with cross-functional teams, manage data collection, conduct reviews, and assist with internal/external audits while promoting continuous improvement within the Quality Systems framework.

To become a Quality Systems Specialist at BD, you should have a Bachelor’s degree in engineering or a related technical discipline combined with at least 3 years of relevant experience, preferably in the Medical Device or Healthcare Industry. Proficiency in data analytics tools like Microsoft Power BI, alongside strong technical writing skills and an understanding of medical device regulations such as EU MDR and ISO 13485, is also essential.

In the role of Quality Systems Specialist at BD, you’ll contribute to continuous improvement objectives by administering PMS training, participating in QA activities, and collaborating with different teams. Your insights and data analysis will help refine processes and enhance compliance with regulatory standards, thus supporting the overall effectiveness of our quality systems.

At BD’s Technology Campus in Bengaluru, you can expect an innovative and collaborative work environment filled with some of the brightest minds in the field. The center emphasizes support for ingenuity and teamwork, promoting a culture where quality and compliance are prioritized to advance health solutions globally.

Success in the Quality Systems Specialist position at BD requires strong analytical and critical thinking skills, excellent communication abilities, and meticulous attention to detail. Familiarity with Good Documentation Practices, along with proficiency in Microsoft Office applications, particularly Word, Excel, and Power BI, will also provide a competitive edge.

In my experience as a Quality Systems Specialist, ensuring compliance with medical device regulations involves staying updated on regulatory changes, facilitating regular training sessions for the team, and meticulously reviewing documentation and processes for consistency with guidelines like EU MDR and ISO 13485.

I have extensive experience in Post Market Surveillance, which involves analyzing data post-launch to monitor device performance and safety. I focus on creating thorough PMS Plans and Reports that comply with regional requirements, leveraging analytical tools to derive meaningful insights from collected data.

Collaboration with cross-functional teams requires clear communication and understanding each team’s objectives. I prioritize regular check-ins, establish shared goals, and utilize project management tools to ensure everyone is aligned and informed about timelines and requirements.

Handling multiple projects efficiently entails strong organizational skills and prioritizing tasks based on deadlines and impact. I employ effective project management techniques, regularly reviewing progress and reallocating resources when needed, to guarantee that quality remains uncompromised.

One challenging situation I faced was during an internal audit that revealed discrepancies in PMS reporting. I promptly collaborated with the involved teams, traced the root cause, and implemented a corrective action plan that included additional training on documentation practices, leading to a successful follow-up audit.

In my previous roles, I have extensively used Microsoft Power BI for data visualization and analysis, alongside Excel for detailed data manipulation. These tools have enabled me to create insightful reports that facilitate informed decision-making regarding device safety and performance.

I stay updated on regulatory changes through regular engagement with industry webinars, subscribing to regulatory newsletters, and participating in professional organizations focused on medical device compliance. This proactive approach ensures that I am informed and can adapt our systems promptly.

Documentation is absolutely crucial in quality systems and compliance as it serves as evidence of adherence to regulations and as a reference for best practices. I ensure all documentation is clear, accurate, and regularly updated to reflect current practices and compliance requirements.

In such a situation, I believe in approaching the disagreement constructively. I would seek to understand their perspective, discuss the data or information backing my stance, and work together to find a solution that prioritizes the project’s success and maintains team harmony.

When training team members on quality assurance processes, clarity is vital. I focus on providing comprehensive resources, hands-on experiences, and encouraging questions to foster understanding. Supplementing training with real-world examples can also enhance engagement and application of concepts.