Quality Systems Specialist: Regulatory & CAPA Focus

Becton Dickinson; Wrocław; On-site; PLN 99,000 - 151,000; Full time

Job summary

BD is seeking a Quality Assurance professional to develop and maintain QMS documentation, support audits, and drive CAPA processes. You will investigate quality issues, analyze data, and assist in continuous improvement across the organization. Strong English communication and teamwork are required for success.

The role emphasizes collaboration with cross-functional teams and exposure to regulatory standards such as ISO 13485 and MDR, in a fixed-term contract setting located in Wroclaw, Poland.

Qualifications

• Bachelor's degree in a relevant field is desirable.
• Experience in Quality Assurance within healthcare or regulated industries.
• Knowledge of ISO 13485 and MDR regulatory requirements.
• Strong written and verbal communication in English.

Responsibilities

• Develop, maintain, and improve QMS documentation and forms.
• Support regulatory inspections, audits, and CAPA processes.
• Investigate quality issues and perform root cause analysis.
• Monitor KPIs and drive continuous improvement initiatives.
• Provide training on quality system requirements.

Skills

Analytical thinking

Problem solving

Communication skills

Team collaboration

Education

Bachelor's degree

Tools

TrackWise

SAP

Microsoft Office

Job description

BD is seeking a Quality Assurance professional to develop and maintain QMS documentation, support audits, and drive CAPA processes. You will investigate quality issues, analyze data, and assist in continuous improvement across the organization. Strong English communication and teamwork are required for success.

The role emphasizes collaboration with cross-functional teams and exposure to regulatory standards such as ISO 13485 and MDR, in a fixed-term contract setting located in Wroclaw, Poland.