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 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 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. Become a maker of possible with us.

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 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) 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 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 CMOs to address and resolve complex issues.
• Audits and Inspections: Serving as the 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 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 and 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.

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…