Complaint Specialist

BD (Becton, Dickinson and Company) • El Paso, TX • 1d ago

Job Description Summary

This role provides support to the entire product complaint process, ensuring compliance with global regulations (such as FDA cGMP and ISO standards), leading, trending, escalating and approving customer complaint investigations. This role serve as the subject matter expert (SME) during audits and work cross-functionally with departments like Quality Assurance, Regulatory Affairs, Manufacturing, and Patient Safety.

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

The essential duties and responsibilities for a Complaints Specialist in the pharmaceutical industry typically include:

Process Oversight: Providing direction and management for the complaint processing team, ensuring all complaints are handled according to established Standard Operating Procedures (SOPs) and global regulatory requirements.

Investigation Management: Overseeing and conducting product complaint investigations, which involves gathering information, coordinating sample returns for evaluation, and determining the root cause.

Regulatory Reporting: Assessing complaints to determine if they are reportable events (e.g., adverse events, medical device reports [MDRs]) and ensuring timely submission to appropriate regulatory agencies like the FDA.

Documentation and Record Keeping: Ensuring accurate and detailed records of all complaint investigations and resolutions are maintained in the Quality Management System (QMS) database.

Trending and Analysis: Performing analysis and trending of complaint data to identify recurring issues, potential risks, and areas for continuous improvement.

Cross-functional Collaboration: Partnering with internal departments (R&D, Manufacturing, Supply Chain, etc.) and external Contract Manufacturing Organizations (CMOs) to address and resolve complex issues.

Audits and Inspections: Serving as the Subject Matter Expert (SME) for the complaint process during internal and external audits and regulatory inspections.

Team Leadership & Mentorship: Coaching, training, and mentoring team members on complaint handling processes and procedures, fostering a culture of compliance and excellence.

Continuous Improvement: Identifying areas for process improvement and leading initiatives or participating in CAPA (Corrective and Preventive Action) activities related to complaint findings.

Minimum Requirements:

Education:

-Bachelor's Degree required (preferably within the Sciences, Engineering, or Clinical fields.)

Experience:

-Previous experience conducting or leading root cause investigations.

-Demonstrated leadership and communication skills with strong attention to detail.

Preferred qualifications:

Advanced degree in a scientific or related discipline preferred.

-Pharma industry experience preferred

-Previous experience presenting during internal or external audits (preferred)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift

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.

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