Quality Systems Manager – Compliance & Process Excellence

Stryker; Skawina; On-site; PLN 158,000 - 264,000; Full time

Job summary

Stryker is seeking an Associate Manager, Quality Systems in Poland to lead a team responsible for maintaining and improving quality processes, driving regulatory compliance, and supporting audits across the organization.

The role requires a minimum of 6 years in quality systems or regulatory roles within the medical device sector, with strong English proficiency and cross-functional collaboration in an international setting.

Qualifications

• Bachelor’s degree or equivalent.
• Minimum 6 years of experience in a Quality Assurance, Quality Systems, or Regulatory Affairs function.
• Experience with medical device quality and regulatory requirements (ISO 13485 and FDA QSR).
• Experience supporting or managing quality system processes such as audits, management reviews, quality planning, document control, CAPA, and change management.
• Experience interacting with regulatory authorities and external auditors.
• Fluent English (minimum B2 level), written and spoken.

Responsibilities

• 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.

Skills

Fluent English

Education

Bachelor’s degree or equivalent

Job description

Stryker is seeking an Associate Manager, Quality Systems in Poland to lead a team responsible for maintaining and improving quality processes, driving regulatory compliance, and supporting audits across the organization.

The role requires a minimum of 6 years in quality systems or regulatory roles within the medical device sector, with strong English proficiency and cross-functional collaboration in an international setting.