Quality Systems Engineer: CAPA & Audit Lead

solique ag; Warsaw (IN); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Medartis is seeking a Quality Systems Engineer to support the Quality Management System across QA and quality improvement functions. You will drive CAPA processes, prepare and respond to audits, and help maintain ISO 13485 compliance.

The role requires strong analytical and problem-solving skills, knowledge of CAPA, and experience with QMS documentation and change controls in the medical device industry.

Competenze

• BS in Engineering or related field or equivalent experience.
• Experience with ISO 13485 and FDA 21 CFR 820.
• CAPA administration, internal/external audit support, and QMS documentation.

Mansioni

• Act as CAPA administrator and lead CAPA reviews.
• Manage external audit activities and liaise with Notified Bodies.
• Coordinate internal audits and report audit metrics.
• Gather KPI data to measure the QMS.
• Assist QMR with annual quality management reviews per ISO 13485:2016.
• Develop and update quality procedures and work instructions.
• Maintain document and change controls within the QMS.
• Ensure compliance with quality system regulations.

Conoscenze

Analytical skills

Problem solving

Root cause analysis

Microsoft Office

Formazione

BS in Engineering or related field

Strumenti

CAPA system

Descrizione del lavoro

Medartis is seeking a Quality Systems Engineer to support the Quality Management System across QA and quality improvement functions. You will drive CAPA processes, prepare and respond to audits, and help maintain ISO 13485 compliance.

The role requires strong analytical and problem-solving skills, knowledge of CAPA, and experience with QMS documentation and change controls in the medical device industry.