Cq Specialist Qms/complaints It

Johnson & Johnson Johnson & Johnson · Pharma · Aprilia, Latina, Italy

The Commercial Quality Specialist, QMS/Complaints IT supports quality management system (QMS) and complaint-handling activities for commercial operations, with a specific focus on IT-enabled processes and systems. This role helps ensure compliant, efficient, and accurate handling of complaints and post-market data in line with regulatory requirements and internal quality standards. The position plays an important role in safeguarding patient safety, strengthening data integrity, and supporting business continuity by partnering closely with Quality, Regulatory Affairs, IT, and Commercial teams.

What you'd actually do

  1. Support commercial quality activities related to QMS and complaint‑handling processes, including IT‑enabled systems and tools.
  2. Ensure compliant and timely handling of complaints, including documentation, system entries, and coordination of investigations.
  3. Support post‑market surveillance and vigilance activities, including adverse event reporting and field action support as required.
  4. Partner with IT, Quality, and Regulatory Affairs teams to support maintenance, improvement, and validation of complaint‑handling and QMS systems.
  5. Support implementation and adherence to global and local QMS procedures, work instructions, and data governance requirements.

Skills

Required

  • Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Information Systems, or a related discipline
  • 2-4 years of experience in Quality, Regulatory, Compliance, or QMS roles within a regulated industry
  • Experience supporting complaint-handling processes and QMS activities
  • Foundational understanding of quality system requirements and regulatory expectations for commercial operations
  • Experience working with IT-enabled quality or complaint management systems
  • Strong attention to detail, documentation, and data accuracy

Nice to have

  • Advanced degree in a scientific, quality, regulatory, or IT-related field
  • Experience in medical devices, healthcare, or other highly regulated industries
  • Familiarity with EU MDR and German regulatory requirements
  • Experience supporting audits, inspections, or health authority interactions
  • Experience working in a multinational or matrixed organization
  • Quality or Regulatory certifications (e.g., ASQ, RAC)
  • Effective communication and cross‑functional collaboration skills
  • German language proficiency

What the JD emphasized

  • required
  • regulated industry
  • complaint-handling processes
  • QMS activities
  • IT-enabled quality or complaint management systems