CQ Specialist QMS/Complaints IT

Job Overview

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. The role ensures compliant, efficient, and accurate handling of complaints and post‑market data in line with regulatory requirements and internal quality standards. It safeguards patient safety, strengthens data integrity, and supports business continuity by partnering with Quality, Regulatory Affairs, IT, and Commercial teams.

Key Responsibilities

• Support commercial quality activities related to QMS and complaint‑handling processes, including IT‑enabled systems and tools.
• Ensure compliant and timely handling of complaints, including documentation, system entries, and coordination of investigations.
• Support post‑market surveillance and vigilance activities, including adverse event reporting and field action support as required.
• Partner with IT, Quality, and Regulatory Affairs teams to maintain, improve, and validate complaint‑handling and QMS systems.
• Support implementation and adherence to global and local QMS procedures, work instructions, and data governance requirements.
• Participate in internal audits, external audits, and health authority inspections related to QMS and complaint systems.
• Monitor quality trends, metrics, and system performance related to complaints and QMS data and support corrective and preventive actions.
• Maintain accurate quality documentation, reports, and system records related to commercial quality activities.

Qualifications

• Education: Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Information Systems, or a related discipline (required). Advanced degree in a scientific, quality, regulatory, or IT‑related field (preferred).
• Experience: 2–4 years 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 experience with IT‑enabled quality or complaint management systems.
• Preferred Skills: Experience in medical devices, healthcare, or other highly regulated industries; familiarity with EU MDR and German regulatory requirements; audit, inspection, or health authority experience; multinational or matrixed organization experience; quality or regulatory certifications (e.g., ASQ, RAC). Strong documentation and data accuracy skills.
• Language: English required; German preferred.
• Travel: Limited; occasional domestic or regional travel.
• Certifications: Quality or Regulatory certifications preferred but not required.

Benefits

Base pay range: €39,800–€64,055. Additional benefits include an annual bonus, vacation days, a minimum 12‑week parental leave, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, financial and health programs, recognition awards, and potential participation in insurance plans depending on location.

Equal Opportunity Employer

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.