Document Control & Change Specialist

Zimmer Biomet; Warszawa; Hybrid; PLN 198,000 - 245,000; Full time

Job summary

Zimmer Biomet is seeking a document control and records management professional to join our quality team in a hybrid role based in Warsaw. You will execute controlled documentation, ensure records are updated, and train peers on processes.

You will develop new documents, manage change control, and identify projects to streamline department workflows. Requires 1–3 years in quality/compliance and familiarity with 21CFR Part 11/820 and ISO 13485.

Qualifications

• BS/BA in engineering, business, life sciences or a similar discipline.
• 1–3 years in Quality Control/Quality Assurance or Compliance, preferably document control in medical devices.
• Knowledge of 21CFR Part 11 & 820, ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems preferred.
• Experience in compliance audits or inspections preferred.
• Change control experience; Windchill knowledge a plus.

Responsibilities

• Trains peers on various processes.
• Authors and develops new documents and processes.
• Manages change control processes and meetings to ensure timely change requests.
• Identifies projects to improve department processes.

Skills

Action oriented

Coaching & mentoring

Strong writing & editing

Attention to detail

Organizational skills

Communication (written & verbal)

Teamwork in global environment

Problem solving

Decision making under pressure

Process development & management

Multi-tasking

Education

BS/BA in engineering, business, life sciences

Tools

MS Office

SharePoint

Job description

Zimmer Biomet is seeking a document control and records management professional to join our quality team in a hybrid role based in Warsaw. You will execute controlled documentation, ensure records are updated, and train peers on processes.

You will develop new documents, manage change control, and identify projects to streamline department workflows. Requires 1–3 years in quality/compliance and familiarity with 21CFR Part 11/820 and ISO 13485.