As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.
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.
Responsibilities:
Consistent application of Quality system standards to assigned Quality system area.
Develops solutions to routine assigned activities of moderate scope & complexity.
Follows applicable Company / Unit procedures and may make updates to procedures and policies
Works within and across functions for assigned Quality systems
Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
Accountable for setting own work direction and completing work tasks.
Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer.
Escalation of complaints and assist in complaint investigations as required.
Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures.
Development of Complaint Closure Letters as required.
Work with Regional Complaint Centers to resolve and address complaint handling issues.Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports.
Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements.
Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.
Files MedWatch reports after Leader reviews and approves if applicable.
Additional Responsibilities:
Contributes to the completion of specific programs and projects.
Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints.
Contribute to the business-wide Quality strategy and objectives.
Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting
Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
Represent BD-MDS on cross-business teams related to Quality Systems.
Qualifications:
Consistent application of Quality system standards to assigned Quality system area.
Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
Prefer a minimum of a Bachelors Degree in a Science Field
Prefer a minimum 3 - 5 years relevant experience or a combination of equivalent education and relevant experience.
Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.
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.
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.
