Senior Quality Engineer - Hybrid (Medical Devices)

Stryker Corporation; Skawina; Hybrid; PLN 107.000 - 179.000; Vollzeit

Zusammenfassung

Position: Quality Engineer at Stryker Corporation in Poland (Skawina). You will partner with manufacturing and cross-functional teams to improve product and process quality, drive CAPA, and lead quality activities across development, validation, and transfers.

Strong analytical skills and knowledge of ISO 13485, GMP, and GDP are valuable. Hybrid work flexibility is offered, with travel up to 10% and a focus on continuous improvement and regulatory compliance in a medical technology setting.

Qualifikationen

• Bachelor's degree in engineering or a related field and at least 2 years in quality.
• Solid understanding of engineering and quality practices and methods.
• Knowledge of ISO 13485, GMP and GDP is advantageous.
• Lean Six Sigma training is a plus.
• Experience with risk-based and statistical techniques (Process Capability, Gauge R&R).
• Process validation experience and strong problem-solving skills.
• Excellent English and Polish, both written and spoken.

Aufgaben

• Partner with manufacturing and cross-functional teams to improve quality performance and drive preventive actions.
• Lead nonconformance and CAPA activities including root cause analysis and corrective actions.
• Drive continuous improvement by analyzing quality indicators and implementing actions.
• Review and challenge change management to ensure robust quality and process effectiveness.
• Lead quality activities for process development, optimization, validation, and transfers.
• Apply risk management to identify process risks and mitigate them.
• Optimize inspection methods, sampling plans, and process monitoring.
• Support audits and interact with regulatory authorities during inspections.

Kenntnisse

Quality practices

Root cause analysis

Statistical methods

Process validation

Risk management

Analytical thinking

English proficiency

Polish proficiency

Lean Six Sigma

Ausbildung

Bachelor of Science, Engineering or related subject

Jobbeschreibung

Position: Quality Engineer at Stryker Corporation in Poland (Skawina). You will partner with manufacturing and cross-functional teams to improve product and process quality, drive CAPA, and lead quality activities across development, validation, and transfers.

Strong analytical skills and knowledge of ISO 13485, GMP, and GDP are valuable. Hybrid work flexibility is offered, with travel up to 10% and a focus on continuous improvement and regulatory compliance in a medical technology setting.