CQ Specialist, QMS & Complaints — Global Quality

Antler Co; Warszawa; On-site; PLN 121,000 - 194,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Job summary

Johnson & Johnson is recruiting for a CQ Specialist QMS/Complaints, located in Warsaw, Poland. This role supports end‑to‑end handling of product complaints, vigilance, field actions/recalls, and other QMS elements to ensure patient safety and regulatory compliance.

Based in a global framework, you will work with cross‑functional partners to drive continuous improvement in quality processes and data integrity while adhering to ISO 13485, FDA QSR, and EU MDR standards.

Qualifications

• Bachelor’s degree required in a scientific, engineering, quality, or related discipline.
• Advanced degree in Quality, Regulatory, or Life Sciences preferred.
• 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.

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.

Skills

Audit Management

Data Analysis

Problem Solving

Detail-Oriented

Regulatory Environment

Quality Management

Internal Controls

Continuous Improvement

Quality Standards

Regulatory Compliance

Education

Bachelor's degree in a scientific, engineering, quality, or related discipline

Advanced degree in Quality, Regulatory, or Life Sciences preferred

Job description

Johnson & Johnson is recruiting for a CQ Specialist QMS/Complaints, located in Warsaw, Poland. This role supports end‑to‑end handling of product complaints, vigilance, field actions/recalls, and other QMS elements to ensure patient safety and regulatory compliance.

Based in a global framework, you will work with cross‑functional partners to drive continuous improvement in quality processes and data integrity while adhering to ISO 13485, FDA QSR, and EU MDR standards.