Senior QMS Specialist – Medical Devices & Compliance

Stryker; Skawina; Remote; PLN 107,000 - 205,000; Full time

Job summary

Stryker Corporation in Skawina, Poland is seeking a Senior Quality Management Systems Specialist to help ensure regulatory compliance and drive continuous QMS improvements. You will support audits, document control, and training programs while coordinating quality planning and reviews.

The role requires a bachelor’s degree, 2+ years in QA/QMS or regulatory roles, ISO 13485 knowledge, and strong English communication. This is a 24‑month fixed-term contract based in Poland.

Qualifications

• Bachelor’s degree or equivalent.
• Minimum 2 years of experience in a Quality Assurance, Quality Systems, or Regulatory Affairs role within regulated environment.
• Knowledge of medical device quality and regulatory requirements, including ISO 13485.
• Fluent English (minimum B2 level), both written and spoken.
• Experience supporting quality system processes such as audits, management reviews, document control, or quality planning.
• Proficiency with standard business software and computer applications.
• Strong communication skills.

Responsibilities

• Ensure compliance of the QMS with global regulatory requirements (FDA, ISO, EU MDR).
• Develop, implement, and improve local and regional QMS processes.
• Serve as local process owner for assigned quality system processes.
• Coordinate management reviews, metrics, and trend analysis.
• Support internal and external audits and address findings.
• Implement and maintain QMS training programs.
• Develop and maintain quality policies, procedures, and controlled docs.
• Lead or support projects to improve quality system effectiveness.

Skills

Fluent English (B2)

Strong communication

Regulatory affairs experience

QA/QMS familiarity

Audits and quality planning

Education

Bachelor’s degree or equivalent

Tools

MS Office / standard software

Job description

Stryker Corporation in Skawina, Poland is seeking a Senior Quality Management Systems Specialist to help ensure regulatory compliance and drive continuous QMS improvements. You will support audits, document control, and training programs while coordinating quality planning and reviews.

The role requires a bachelor’s degree, 2+ years in QA/QMS or regulatory roles, ISO 13485 knowledge, and strong English communication. This is a 24‑month fixed-term contract based in Poland.