Senior Quality Management Systems (QMS) Specialist

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

## Senior Quality Management Systems (QMS) SpecialistApply: Skawina, Poland: Full time: Posted Today: R572625Work Flexibility: Not availableJoin a team that helps ensure the highest quality standards across a global medical technology organization. In this role, you will contribute to the development, maintenance, and continuous improvement of quality management systems that support regulatory compliance, operational excellence, and business growth. Your work will directly support patient safety, product quality, and organizational success.**What You Will Do*** Ensure compliance of the Quality Management System (QMS) with applicable global regulatory requirements, including FDA, ISO standards, EU Medical Device regulations, and country-specific requirements.* Develop, implement, and continuously improve local and regional quality management system processes aligned with global quality standards and business needs.* Serve as a local process owner for assigned quality system processes, ensuring effectiveness, compliance, and ongoing process improvement.* Coordinate management reviews and quality planning reviews, including preparation of metrics, trend analysis, and follow-up actions.* Support internal and external audits by coordinating activities, maintaining documentation, and driving timely resolution of findings.* Implement and maintain QMS training programs to ensure employee compliance with quality requirements and procedures.* Develop, maintain, and update quality policies, procedures, and controlled documentation to support business operations.* Lead or support projects to enhance quality system effectiveness, assess regulatory requirements, implement best practices, and drive continuous improvement initiatives.**What You Will Need****Required 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 and applicable global regulations.* 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.**Preferred Qualifications*** Experience working within the medical device industry.* Knowledge of Medical Device Single Audit Program (MDSAP) requirements and U.S. FDA Quality System Regulations (21 CFR Part 820).* Experience participating in or leading quality system improvement projects.**Please note it is a 24-month fixed term contract****Poland Pay Ranges:*** **Poland, Skawina**: zł107.100 - zł178.600 PLN Annual* **Poland**: zł123.200 - zł205.400 PLN AnnualAt Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.Travel Percentage: None