CQ Specialist QMS/Compliants

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. Learn more at jnj.com . 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. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Prague, Czechia, Warsaw, Masovian, Poland Job Description: DePuy Synthes is recruiting for a CQ Specialist QMS/Compliants, located in Warsaw Poland. Job Overview The CQ Specialist, QMS / Complaints plays a critical role within QARA International by supporting the effectiveness and compliance of the Quality Management System (QMS), focusing on end ‑ to ‑ end handling of product complaints, vigilance, field action/recall and supporting the execution of other QMS elements. This role directly supports patient safety, regulatory compliance, and continuous improvement across DePuy Synthes’ international markets. The position offers strong exposure to global and local quality processes, cross ‑ functional collaboration, and regulated medical device environments. Key Responsibilities Support the execution and maintenance of the Quality Management System (QMS) in alignment with internal procedures and applicable global regulations. Process, document, and track product complaints in accordance with regulatory and internal requirements, ensuring timely and accurate resolution. Support complaint investigation activities, including data collection, trend analysis, documentation of findings, and follow-up of required actions. Support regulatory reporting activities related to complaints, adverse events, and vigilance requirements, as applicable. Support Field Actions, Recalls, and other post-market quality activities by maintaining documentation, tracking actions, and supporting execution in accordance with internal and regulatory requirements. Maintain accurate quality records and ensure data integrity within quality systems and databases. Support the execution of other QMS elements and quality processes as assigned, in accordance with company procedures. Participate in audits, inspections, and internal assessments by preparing documentation and supporting responses. Analyze complaint and quality data to identify trends, gaps, potential risks, and opportunities for continuous improvement within complaint and QMS processes. Collaborate with cross-functional partners, including Manufacturing, R&D, Regulatory Affairs, and Customer Service, to support quality outcomes and effective issue resolution. Contribute to continuous improvement initiatives that strengthen QMS effectiveness, regulatory compliance, patient safety, and product quality. Qualifications Education Bachelor’s degree required in a scientific, engineering, quality, or related discipline. Advanced degree in Quality, Regulatory, or Life Sciences preferred. Experience and Skills Required: Typically 0–2 years of professional experience in Quality, Regulatory, Compliance, or a regulated industry environment. Foundational knowledge of Quality Management Systems and controlled documentation. Strong attention to detail and ability to manage quality records accurately. Ability to analyze data, identify trends, and support root ‑ cause activities at a basic level. Effective written and verbal communication skills. Preferred: Experience supporting medical device or pharmaceutical complaint handling processes. Familiarity with global quality and regulatory standards (e.g., ISO 13485, FDA QSR, EU MDR). Experience working with electronic QMS or complaint management systems. Experience in an international or matrixed organization. </