Job Description Summary

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

DCHU (Designated Complaint Handling Unit )represents the customer facing department responsible for Post-market surveillance, signal detection (complaints, adverse events) The team is responsible for customer complaint lifecycle management, monitoring product/service quality through the complaint process, facilitating continuous improvement driven by the CAPA system, and generating complaint data, trending and analysis. This team is accountable for providing insight to assist with prioritizing business opportunities and product/service solutions for our Medication and Procedural Solutions businesses.

Areas of responsibility include post-market surveillance through product lifecycle complaint process, signal detection, domestic and international customer and agency notifications and/or communication, and risk management activities in compliance with European Medical Device Directive, Canadian Medical Device Regulations, ISO 13485, FDA QSR Parts 803, 806 & 820, J-PAL, and ISO 14971.

The major activities of the incumbent are:

Producing high impact results and resolving complex customer escalation issues and requirements.

• Responsible for robust post-production monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.

• Develops post-market surveillance metrics and measurement systems (i.e. trends, Pareto analysis, and statistical analysis) that enable meaningful strategies to be constructed for optimal root cause resolution, customer satisfaction, and regulatory compliance.

• Facilitates cross-functional interaction and communication between QRA, RD&E, Manufacturing, Operations, Sales, and Marketing and Vendor oversight related to the customer experience and expectations. Responsible for scheduling, coordinating, and execution of regular, meaningful Customer Care meetings. This includes conducting effectiveness checks and internal assessments of current processes and procedures to identify potential process improvement opportunities and adherence to KPI’s.

• Point of Contact (PoC) for post-market surveillance/complaint information in Pilgrim, CRS and Trackwise as requested by business (i.e. manufacturing facility).

• Interacts directly with customers, as well as business, including traveling to distribution sites, customer, and/or manufacturing sites as needed, in order to appropriately assess the customer experience.

• Reviews medical/scientific literature and participates in product training to maintain expertise and current awareness of relevant issues to products. Provides post-market surveillance/complaint input into 510(k)’s, NDA’s and IND’s technical files.

• Assists with and provides data and metrics in support of risk management activities.

• Participates in and supports recall activities by providing validated consignee lists, management of reconciliation of recall responses, creation and maintenance of well-organized recall binder, and other activities as requested.

Knowledge

• Consistent application of Quality system standards to assigned Quality system area.

• Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements

Skills

• Competencies include: Strong clinical/technical acumen, excellent verbal and written communication, strong multi-task & situational management, personal & team leadership, strong interpersonal skills, excellent computer skills, and strong results orientation are required for effective performance in this role.

• Must be capable of interfacing with senior level health care executives and be able to resolve complex customer service issues.

Education/Degree

• Typically requires a minimum of a Bachelor’s Degree

• Certifications (if applicable)

Experience

• Prefer a minimum 3 years relevant experience or a combination of equivalent education and relevant experience.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work 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. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.

To learn more about BD visit https://bd.com/careers

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.

PDN

Primary Work Location

USA IL – Vernon Hills

Additional Locations

Work Shift