Complaint Specialist

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 serves as the subject matter expert (SME) during audits and works cross‑functionally with departments such as 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 Med Tech 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.

• 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, 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.

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

• 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 onsite 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 four days of in‑office presence per week. Remote or field‑based positions will have different workplace arrangements indicated in the job posting. For certain roles, employment is contingent upon proof of full vaccination against COVID‑19.

Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and…