Quality Systems Lead, Medical Devices – Onsite (Poland)

Stryker; Skawina; Remote; PLN 158,000 - 264,000; Full time

Job summary

Stryker Corporation in Skawina, Poland, is seeking an Associate Manager, Quality Systems to lead a team responsible for quality processes, CAPAs, document control, and change management in a regulated medical device environment.

You will ensure ISO 13485 and FDA quality system compliance, coordinate audits, drive CAPA effects, and mentor cross-functional teams while promoting continuous improvement and training.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Minimum 6 years in Quality Assurance, Quality Systems, or Regulatory Affairs.
• Experience with ISO 13485 and FDA quality system regulations.
• Experience supporting audits, management reviews, and change management.
• Experience interacting with regulatory authorities and external auditors.
• Fluent English (written and spoken).

Responsibilities

• Lead and develop a team of Quality Systems professionals with clear objectives.
• Manage quality system processes: CAPA, document control, change management, quality records.
• Ensure compliance with ISO 13485 and FDA QSRs across the organization.
• Coordinate internal and external audits and close audit observations.
• Partner with cross-functional teams to investigate issues and implement corrective actions.
• Deliver quality systems training and monitor training records for compliance.
• Drive continuous improvement by analyzing trends and reducing risk.

Skills

Team leadership

English proficiency

Regulatory awareness

Education

Bachelor’s degree or equivalent

Master’s degree or PhD

Tools

Office software

Job description

Stryker Corporation in Skawina, Poland, is seeking an Associate Manager, Quality Systems to lead a team responsible for quality processes, CAPAs, document control, and change management in a regulated medical device environment.

You will ensure ISO 13485 and FDA quality system compliance, coordinate audits, drive CAPA effects, and mentor cross-functional teams while promoting continuous improvement and training.