The Complaint Management Specialist position supports and provides oversight of product complaint handling and Post Market Surveillance activities. This individual must have a customer centric focus while interacting with customers, as well as other team members in professional services and quality. Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.
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.
Position Summary: The Complaint Management Specialist position supports and provides oversight of product complaint handling and Post Market Surveillance activities. This individual must have a customer centric focus while interacting with customers, as well as other team members in professional services and quality. Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.
Oversight and support of global compliant handling; including but not limited to; intake of complaints (direct phone calls for initial reports (in lieu of emails) and additional follow ups via phone/ email interaction with physicians, sales representatives, internal customers &/or patients is required at this phase); investigation of complaints (lab work on site in Tempe, Arizona will be required at this phase) and closure of complaints (writing and submitting regulatory reports (both US and OUS) and completing customer response letters will be required at this phase).
Work collaboratively with BD investigative lab and/or supplier(s) to pass on any pertinent details quickly from customer calls or correspondence.
Monitor any death or serious injury medical device report (MDR) records through investigation completion to closure ensuring that the adverse event information is comprehensive and meets target timeframes for closure.
This position will be a subject matter expert for audits or assessments on adverse events.
Ability to review and summarize medical journal articles received throughout BD on PI devices to assess if they represent reportable adverse events for medical device reporting.
Raise awareness of adverse events to legal, corporate, and management teams.
Periodically review and revise MDR Reportability Guidelines to incorporate current failure modes and reportability determinations, expediting the procedural changes through document control.
Work with peers/suppliers to ensure changes to automated tools are updated based on updated work instructions and MDR Reportability Guidelines.
Ability to multi-task and work in a fast-paced environment with critical importance on timely MDR submissions.
Sampling of complaints completed by supplier (intake and/or investigations).
Support internal and external supplier audits on site.
Develop and implement procedures to comply with corporate and industry standards.
Support and/or lead CAPA activities associated with product complaints.
Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
Education and Experience:
Bachelor's Degree is required for this position. Engineering or Nursing degree being preferred.
A minimum of 3 years of professional experience directly related to the degree.
Experience in CAPA, QMS Auditing, Document/Change Control, Training, and Records Management, preferably in medical devices is also preferred.
Ability to collect, analyze and present clinical data. Must be proficient with computer (Word, PowerPoint, Excel, etc.)
Able to assess problems and overcome objections.
Professional attitude and appropriate business and clinical judgment in all aspects of this position.
Must be able to collaborate with all levels of the organization and with customers at various levels of the health care facility (clinical staff, biomed, risk management).
Must have effective interpersonal, telephone, and communication skills (both written and verbal).
Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook) required. Experience with TrackWise, SAP, MS Teams, preferred.
Understanding of regulatory requirements (including but not limited to: ISO 13485, ISO 14971, etc.)
Knowledge and Skills:
Effective oral and written communication skills targeted at all levels within the company.
Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.
Project management utilizing analytical, technical, and problem-solving skills.
Able to perform multiple complex tasks & prioritize workloads & activities for large volumes of complaints.
Strong organizational skills & proven ability to meet deadlines in an environment of competing priorities.
Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise)
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
Demonstrated ability to successfully interact with regulatory authorities during inspections & audit related to complex technical documentation; defending failure investigation activities as failure investigation SME during inspections is a plus.
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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.
