Quality Systems Specialist - Medical Devices & Compliance

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

Job summary

BD is recruiting for a Quality Assurance professional in Wroclaw, Poland to develop and maintain QMS documentation and support regulatory inspections. The role involves root cause analysis, CAPAs, KPI reporting, and driving continuous improvement across processes with TrackWise and SAP proficiency.

You will collaborate with cross‑functional teams, deliver training on quality system requirements, and ensure compliance with MDR and ISO13485, in a fast‑paced healthcare environment.

Qualifications

• Minimum Bachelor’s Degree is desirable.
• Experience in Quality Assurance within the healthcare, medical device, pharmaceutical or regulated industry environment.
• Strong understanding of quality management systems (e.g., ISO 13485) and regulatory requirements (e.g., MDR).
• Demonstrated experience investigating quality issues, performing root cause analysis, and implementing effective CAPAs.
• Excellent analytical, critical thinking, and problem-solving skills, with the ability to interpret data and identify trends.
• Strong written and verbal communication skills in English, with the ability to effectively communicate across all levels of the organization.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and electronic QMS platforms (e.g. Trackwise, SAP).
• Ability to work independently and as part of a team in a fast‑paced environment.

Responsibilities

• Develop, maintain, and continuously improve Quality Management System (QMS) documentation, including procedures, work instructions, templates, and forms, ensuring alignment with applicable regulatory and business requirements.
• Support regulatory inspections, certification audits, and internal and external audits by preparing documentation, coordinating responses, and providing subject matter expertise as required.
• Investigate quality-related issues, nonconformances, and customer complaints, conduct root cause analysis, and support the implementation and effectiveness verification of corrective and preventive actions (CAPAs).
• Monitor, analyze, and report quality system metrics and key performance indicators (KPIs), identifying trends and opportunities for improvement.
• Deliver training and support employee awareness of quality system requirements, while driving continuous improvement through process evaluations, gap assessments, and enhancement initiatives.
• Coordinate quality system databases, trackers, and electronic systems (e.g., TrackWise, SAP, C2C), ensuring data accuracy and timely completion of assigned activities and actions.
• Lead and support Quality Systems projects and improvement initiatives, acting as a Subject Matter Expert (SME) for assigned processes and responsibilities as defined within QMS documentation.
• Collaborate with cross-functional stakeholders to support quality system compliance, issue resolution, and implementation of process improvements.

Education

Bachelor's Degree

Job description

BD is recruiting for a Quality Assurance professional in Wroclaw, Poland to develop and maintain QMS documentation and support regulatory inspections. The role involves root cause analysis, CAPAs, KPI reporting, and driving continuous improvement across processes with TrackWise and SAP proficiency.

You will collaborate with cross‑functional teams, deliver training on quality system requirements, and ensure compliance with MDR and ISO13485, in a fast‑paced healthcare environment.