Complaint Specialist

Becton Dickinson Medical Devices • El Paso, TX

10d • Onsite

About The Position

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. 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.

Requirements

• Bachelor’s Degree required (preferably within the Sciences, Engineering, or Clinical fields.)
• 2-4 years of complaint handling, post market surveillance, or quality system experience in medical device industry (required). Pharma, preferred.
• Previous experience conducting or leading root cause investigations.
• Demonstrated leadership and communication skills with strong attention to detail.

Nice To Haves

• Advanced degree in a scientific or related discipline preferred.
• Pharma industry experience preferred
• Previous experience presenting during internal or external audits (preferred)

Responsibilities

• 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.
• Overseeing and conducting product complaint investigations, which involves gathering information, coordinating sample returns for evaluation, and determining the root cause.
• 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.
• Ensuring accurate and detailed records of all complaint investigations and resolutions are maintained in the Quality Management System (QMS) database.
• Performing analysis and trending of complaint data to identify recurring issues, potential risks, and areas for continuous improvement.
• Partnering with internal departments (R&D, Manufacturing, Supply Chain, etc.) and external Contract Manufacturing Organizations (CMOs) to address and resolve complex issues.
• Serving as the Subject Matter Expert (SME) for the complaint process during internal and external audits and regulatory inspections.
• Coaching, training, and mentoring team members on complaint handling processes and procedures, fostering a culture of compliance and excellence.
• Identifying areas for process improvement and leading initiatives or participating in CAPA (Corrective and Preventive Action) activities related to complaint findings.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees