CQ Specialist QMS/Complaints (Medical Devices)

Location: Hybrid role based in Warsaw, Poland; Prague, Czechia is also listed among the job posting locations. Minimal international travel is expected, generally under 10%.

Salary: PLN 121,000–194,350 annual base pay.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions through its DePuy Synthes business.

What you will do

• Support the execution and maintenance of the Quality Management System in line with internal procedures and global regulations.
• Process, document, track, and support investigations of product complaints, including trend analysis and follow-up actions.
• Support regulatory reporting for complaints, adverse events, and vigilance requirements.
• Maintain documentation for field actions, recalls, post-market activities, and quality records.
• Prepare documentation for audits, inspections, and internal assessments.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Customer Service on issue resolution and continuous improvement.

Requirements

• Bachelor’s degree in a scientific, engineering, quality, or related discipline.
• Typically 0–2 years of experience in Quality, Regulatory, Compliance, or another regulated industry.
• Foundational knowledge of Quality Management Systems and controlled documentation.
• Strong attention to detail, data analysis, communication, and basic root-cause analysis skills.
• English proficiency and Polish required for local operations.

Nice to have

• Experience with medical device or pharmaceutical complaint handling.
• Knowledge of ISO 13485, FDA QSR, or EU MDR.
• Experience with electronic QMS or complaint management systems.
• Experience in an international or matrixed organization.
• Quality or Regulatory certifications such as ASQ.

Culture & Benefits

• Inclusive work environment focused on employee dignity, diversity, and equal opportunity.
• Annual bonus based on pay grade, location, and employee and company performance.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans and service anniversary and recognition awards, subject to applicable plan terms.