Senior Quality Management Systems (QMS) Specialist

Stryker Group; Skawina; On-site; PLN 107,000 - 179,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

2+ years QA experience

ISO 13485 knowledge

Quality systems experience

Audits & quality planning

Communication skills

MS Office proficiency

Fluent English (B2)

Education

Bachelor’s degree or equivalent

Tools

MS Office

Job description

Join 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: 107.100 - 178.600 PLN gross annual

At 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.