CQ Specialist Core QMS

Support the maintenance, implementation, and continuous improvement of the Core Quality Management System (QMS). Author, review, and update global quality procedures, work instructions, and related documentation. Ensure QMS processes align with applicable regulatory requirements (e.g., ISO 13485, FDA QSR, MDR) and internal standards. Support internal, external, and regulatory audits, including preparation, execution, and follow‑up of corrective actions. Track, analyze, and report QMS metrics and performance indicators to support data‑driven decision‑making. Collaborate with cross‑functional stakeholders to assess process changes and support change management activities. Support CAPA, deviation, and continuous improvement initiatives related to QMS processes. Contribute to training activities to ensure effective understanding and adoption of QMS requirements.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related discipline

• Approximately 3–5 years of relevant experience in Quality, Compliance, or Regulatory Affairs within a regulated industry, preferably medical devices

• Working knowledge of Quality Management Systems and global quality standards

• Experience supporting audits and inspection readiness activities

• Ability to analyze quality data and support continuous improvement initiatives

• Fluency in English required; German preferred

• Limited travel; Up to 10%, primarily international

• ASQ or equivalent Quality certification preferred