Senior QMS Specialist - Quality & Regulatory Compliance

Stryker Group; Skawina; Vor Ort; PLN 107.000 - 179.000; Vollzeit

Zusammenfassung

Stryker Group is seeking a Quality Management System professional in Poland to strengthen regulatory compliance and operational excellence. You will contribute to developing, maintaining, and improving QMS processes that support patient safety and product quality across regions.

The role focuses on regulatory compliance, process optimization, and collaboration with audits and training programs, with a 24-month fixed-term contract.

Qualifikationen

• Bachelor’s degree or equivalent.
• Minimum 2 years of experience in QA/Quality Systems or Regulatory affairs.
• Knowledge of ISO 13485 and applicable global medical device regulations.
• Fluent English (min B2), written and spoken.
• Experience supporting QA processes such as audits, management reviews, document control, or quality planning.
• Proficiency with standard business software and strong communication skills.

Aufgaben

• Ensure QMS compliance with FDA, ISO standards, EU Medical Device regs, and country-specific requirements.
• Develop, implement, and continuously improve local and regional QMS processes aligned with global standards.
• Serve as a local process owner for assigned quality system processes.
• Coordinate management reviews and quality planning with metrics, trend analysis, and follow-up actions.
• Support internal and external audits by coordinating activities and resolving findings.
• Implement and maintain QMS training programs for employee compliance.
• Develop, maintain, and update quality policies, procedures, and controlled documentation.
• Lead or support projects to enhance quality system effectiveness and drive improvements.

Kenntnisse

2+ years QA experience

ISO 13485 knowledge

Quality systems experience

Audits & quality planning

Communication skills

MS Office proficiency

Fluent English (B2)

Ausbildung

Bachelor’s degree or equivalent

Tools

MS Office

Jobbeschreibung

Stryker Group is seeking a Quality Management System professional in Poland to strengthen regulatory compliance and operational excellence. You will contribute to developing, maintaining, and improving QMS processes that support patient safety and product quality across regions.

The role focuses on regulatory compliance, process optimization, and collaboration with audits and training programs, with a 24-month fixed-term contract.