Senior Quality Engineer – Medical Devices (Hybrid, Poland)

Stryker Corporation; Polska; Hybrid; PLN 107,000 - 179,000; Full time

Job summary

Stryker Corporation in Skawina, Poland, is seeking a Senior Quality Engineer to influence product and process quality across manufacturing operations. The role involves partnering with cross-functional teams, driving preventive quality, leading CAPA activities, and supporting audits in a medical technology environment.

You will lead continuous improvement, apply risk-based and statistical techniques, and contribute to process validation and product transfers between facilities while ensuring

Qualifications

• Bachelor of Science, Engineering or related subject and minimum 2 years of work experience in a quality discipline.
• Good understanding of engineering and quality practices & methods.
• Knowledge of ISO 13485, GMP, and GDP requirements would be an advantage.
• Lean Six Sigma training is a distinct advantage.
• High level knowledge of risk-based and statistical techniques, including process risk, sampling plans, CP, and R&Rs.
• Experience in validation of processes.
• Excellent English and Polish (oral and written).
• Ability to be the voice of Quality when dealing cross functionally.

Responsibilities

• Partner with manufacturing and cross-functional teams to improve product and process quality performance and drive preventive quality activities.
• Lead and support nonconformance and corrective/preventive action activities, including root cause analysis and implementation of effective corrective actions.
• Drive continuous improvement initiatives by analyzing quality performance indicators and implementing actions to improve results.
• Review, approve, and challenge change management activities to ensure robust quality and process effectiveness.
• Lead quality-related activities for manufacturing process development, optimization, validation, and product transfers between facilities.
• Apply risk management methodologies to identify process risks, evaluate mitigation strategies, and strengthen process controls.
• Optimize inspection methods, statistical sampling plans, and process monitoring approaches to enhance quality assurance effectiveness.
• Support and lead internal and external audits, including interactions with regulatory authorities, and provide quality expertise during inspections and reviews.

Education

Bachelor of Science in Engineering or related subject

Job description

Stryker Corporation in Skawina, Poland, is seeking a Senior Quality Engineer to influence product and process quality across manufacturing operations. The role involves partnering with cross-functional teams, driving preventive quality, leading CAPA activities, and supporting audits in a medical technology environment.

You will lead continuous improvement, apply risk-based and statistical techniques, and contribute to process validation and product transfers between facilities while ensuring