Complaint Management Specialist I

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.

Position Summary: This position supports and provides oversight of product complaint handling and Post Market Surveillance activities.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Oversight and support of global compliant handling; including but not limited to, intake of complaints (Direct phone &/or email interaction with physicians, sales representatives, internal customers &/or patients is required at this phase)/investigations (lab work on site in Tempe, Arizona may be required at this phase)/closure (writing and submitting regulatory reports (both US and OUS) and completing customer response letters may be required at this phase).
• Sampling of complaints completed by supplier (intake and/or investigations).
• Ability to make and present risked based decisions.
• Support the development and revision of reportability guidelines.
• Support internal and external supplier audits.
• Provide support to Post Market Quality in responding to additional information requests from regulatory agencies.
• Develop and implement procedures to comply with corporate and industry standards.
• Support the evaluation of returned complaint devices through training, developing test methods, and leading equipment qualifications.
• Support and/or lead CAPA activities associated with product complaints.
• Provide monthly analysis of complaint data for assigned products, i.e., CID creation, C Chart commentary, ESDS analysis/evaluation.
• Quality engineering representation (complaint related) on Product Development Teams
• Participate in project planning, scheduling, and tracking.
• Complies with company procedures and policies, government regulations.
• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
• Other duties and projects, as assigned.

Required Qualifications:

• Knows how products are used and impact the user(s) so that risk can be managed effectively
• Ability to develop solutions with business impact
• Statistical and risk assessment techniques
• Ability to make and present risk-based decisions
• Strong interpersonal skills
• Ability to analyze and optimize manufacturing and quality systems
• Ability to create and provide training
• Problem solving ability
• Oral and written presentation skills
• Ability to participate on cross functional teams
• Understanding of regulatory requirements including ISO 13485, ISO 14971

Preferred Qualifications:

• Working knowledge of compliant handling system(s) (i.e., Trackwise, Service Max, GCS)

Education and/or Experience:

• Bachelor's degree required. In lieu of a degree, 5 or more years of relevant experience may suffice.

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.

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 AZ - Tempe Headquarters

Additional Locations

Work Shift