Senior Quality Engineer — Hybrid, Drive Quality & Compliance

Stryker Corporation; Poland; Hybrid; Confidential; Full time

Benefits offered by this job

Hybrid work model

Job summary

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

Responsibilities include leading CAPA activities, risk-based process validation, and refining inspection and sampling methods to strengthen quality controls; strong English and Polish

Qualifications

• Bachelor-level engineer with 2+ years in a quality discipline.
• Experience with ISO 13485, GMP and GDP is preferred.
• Strong problem solving and analytical skills, with cross-functional collaboration.

Responsibilities

• Partner with manufacturing and cross-functional teams to improve quality performance and drive preventive quality activities.
• Lead and support 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 manufacturing process development, optimization, validation, and product transfers.
• Apply risk management to identify process risks and mitigation strategies.
• Optimize inspection methods and sampling plans to strengthen QA controls.
• Support audits and regulatory inspections with quality expertise.

Skills

Quality practices & methods

Problem solving

English & Polish language proficiency

Lean Six Sigma training

Risk based & statistical techniques

Process validation

Process capability

Gage R&R

Education

Bachelor of Science, Engineering or related subject

Job description

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

Responsibilities include leading CAPA activities, risk-based process validation, and refining inspection and sampling methods to strengthen quality controls; strong English and Polish