Quality Systems Engineer – CAPA & QA Auditor

Medartis Inc. - United States; Warszawa; On-site; PLN 327,000 - 462,000; Full time

Job summary

Medartis seeks a Quality Systems Engineer to support the Quality Management System, quality assurance and continuous quality improvement across the organization. The role focuses on CAPA administration, audit activities with the Notified Body and customers, and KPI data management.

You will assist QMR in annual reviews, develop procedures, and ensure controls and documentation comply with ISO 13485:2016 and regulatory requirements. Join a global medtech leader in orthopaedics.

Qualifications

• BS in Engineering or related field preferred, or equivalent experience
• Working knowledge of medical device regulations (ISO 13485; FDA 21 CFR 820)
• Basic knowledge of statistics and engineering principles
• Strong analytical and problem-solving skills
• Proficient with MS Office applications

Responsibilities

• Act as CAPA administrator by facilitating CAPA system and leading CAPA review board meetings to ensure compliance
• Manage external audit activities including certification audits and customer audits, liaising with external parties and reporting metrics
• Facilitate all internal audit activities: planning resources, scheduling, and reporting metrics
• Gather and manage KPI/metric data used to measure the QMS
• Assist Quality Management Representative (QMR) in conducting annual quality management reviews per ISO 13485:2016
• Create and update procedures and work instructions to capture improvements to QMS processes
• Assist subject matter experts in development, authoring and releasing procedures and work instructions for their processes
• Maintain document controls and change controls within the QMS
• Ensure processes and documentation comply with quality system regulations

Skills

Analytical skills

Problem solving

Root cause analysis

Statistical principles

Engineering principles

Education

BS in Engineering or related field

Tools

Microsoft Office

Job description

Medartis seeks a Quality Systems Engineer to support the Quality Management System, quality assurance and continuous quality improvement across the organization. The role focuses on CAPA administration, audit activities with the Notified Body and customers, and KPI data management.

You will assist QMR in annual reviews, develop procedures, and ensure controls and documentation comply with ISO 13485:2016 and regulatory requirements. Join a global medtech leader in orthopaedics.