Quality Systems Leader – Compliance & Improvement

Stryker (old); Polska; Hybride; PLN 158 000 - 264 000; Plein temps

Résumé du poste

Stryker Group in Poland, Skawina, seeks an Associate Manager, Quality Systems to lead a team responsible for maintaining and improving quality processes, ensuring regulatory compliance, and supporting sustainable business growth.

You will manage corrective and preventive actions, document control, change management, and quality records; coordinate internal and external audits; and partner with cross-functional teams to reduce risk and drive continuous improvement across the organization.

Qualifications

• Bachelor’s degree in a relevant field.
• Minimum 6 years of experience in a Quality Assurance, Quality Systems, or Regulatory Affairs function.
• Experience with medical device quality and regulatory requirements, including ISO 13485 and FDA quality system regulations.
• Experience supporting or managing quality system processes such as audits, management reviews, quality planning, document control, corrective and preventive actions, and change management.
• Experience interacting with regulatory authorities and external auditors.
• Experience leading and developing teams and working in a cross-functional, international environment.
• Fluent English (minimum B2 level), written and spoken.
• Advanced proficiency with standard business and computer applications.

Responsabilités

• Lead and develop a team of Quality Systems professionals by setting clear objectives, providing coaching, and supporting career development to achieve quality and compliance goals.
• Manage quality system processes, including corrective and preventive actions, document control, change management, and quality records, ensuring compliance with applicable regulations and internal standards.
• Ensure ongoing compliance with global quality and regulatory requirements, including ISO 13485 and applicable FDA regulations.
• Coordinate and support internal and external audits, drive audit readiness activities, and ensure timely closure of audit observations and corrective actions.
• Partner with cross-functional teams to investigate quality issues, implement corrective and preventive actions, and reduce compliance risks.
• Oversee the documentation, review, investigation, and resolution of nonconformances in accordance with established procedures.
• Deliver and maintain quality systems training programs, ensuring training records and certifications remain current and compliant.
• Drive continuous improvement initiatives by monitoring quality system performance, analyzing trends, and implementing process enhancements that improve effectiveness and reduce risk.

Connaissances

Leadership

Quality Systems

Audits

ISO 13485

FDA compliance

Cross-functional

English fluency

Training & coaching

Formation

Bachelor’s degree

Master’s degree or PhD

Outils

Office software

Description du poste

Stryker Group in Poland, Skawina, seeks an Associate Manager, Quality Systems to lead a team responsible for maintaining and improving quality processes, ensuring regulatory compliance, and supporting sustainable business growth.

You will manage corrective and preventive actions, document control, change management, and quality records; coordinate internal and external audits; and partner with cross-functional teams to reduce risk and drive continuous improvement across the organization.