Senior Quality Management Systems (QMS) Specialist

About the role

Join Stryker’s global medical technology team to ensure the highest quality standards across products and processes. You will develop, maintain, and continuously improve quality management systems that support regulatory compliance, operational excellence, and patient safety.

Key responsibilities

• Ensure the QMS complies with global regulations such as FDA, ISO 13485, EU Medical Device directives and country‑specific requirements.
• Develop, implement and improve local and regional QMS processes aligned with global standards and business needs.
• Act as the local process owner for assigned quality system processes, coordinating management reviews, quality planning, metrics, trend analysis and follow‑up actions.
• Support internal and external audits, maintain documentation and drive timely resolution of findings.
• Implement and maintain QMS training programs and keep quality policies, procedures and controlled documents up to date.
• Lead or support projects aimed at enhancing QMS effectiveness, assessing regulatory changes and driving continuous improvement.

Required profile

• Bachelor’s degree or equivalent.
• Minimum 2 years of experience in Quality Assurance, Quality Systems or Regulatory Affairs within a regulated environment.
• Fluent English (minimum B2) – written and spoken.
• Experience with audits, management reviews, document control or quality planning.

Required skills

• Knowledge of ISO 13485 and other global medical device regulations.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820) and the Medical Device Single Audit Program (MDSAP).
• Proficiency with standard business software and computer applications.