Senior Quality Engineer: Lead Process Quality & CI

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

Job summary

Stryker is seeking a Quality Engineer in Poland to drive product and process quality across manufacturing and business functions in a medical technology setting. You will partner with cross-functional teams to lead improvement initiatives, support audits, and ensure compliance with regulatory standards.

Strong analytical and problem solving skills are essential. The role requires a Bachelor’s degree in engineering or related field, at least two years in quality, and knowledge of ISO 13485, GMP,

Qualifications

• Bachelor’s degree in engineering or related field with 2+ years in quality discipline.
• Knowledge of ISO 13485, GMP, GDP advantageous.
• Lean Six Sigma training advantageous.
• Strong problem solving and analytical skills.

Responsibilities

• Partner with manufacturing to improve product and process quality performance and lead preventive quality activities.
• Lead and support nonconformance and CAPA activities, including root cause analysis and corrective actions.
• Drive continuous improvement by analyzing quality metrics and implementing actions.
• Review and challenge change management for robust quality and process effectiveness.
• Lead quality activities for manufacturing process development, validation, and transfers.
• Apply risk management to identify process risks and mitigation strategies.
• Optimize inspection, sampling, and process monitoring for QA effectiveness.
• Support internal and external audits and interact with regulatory authorities.

Skills

Problem solving

Analytical thinking

English proficiency

Polish proficiency

Quality systems knowledge

Education

Bachelor of Science in Engineering

Job description

Stryker is seeking a Quality Engineer in Poland to drive product and process quality across manufacturing and business functions in a medical technology setting. You will partner with cross-functional teams to lead improvement initiatives, support audits, and ensure compliance with regulatory standards.

Strong analytical and problem solving skills are essential. The role requires a Bachelor’s degree in engineering or related field, at least two years in quality, and knowledge of ISO 13485, GMP,