Senior Quality Engineer

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

## Senior Quality EngineerApply: Skawina, Poland: Full time: Posted Yesterday: R571484Work Flexibility: Hybrid**Make an impact on quality, patient safety, and continuous improvement.** As a Quality Engineer, you will play a key role in ensuring product and process quality across manufacturing operations and business functions. This is an exciting opportunity to influence quality performance, lead improvement initiatives, and drive compliance with regulatory and industry standards while partnering with cross-functional teams in a dynamic medical technology environment. # **What you will do*** 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. # **What do you need:*** Bachelor of Science, Engineering or related subject and minimum 2 years of work experience in a quality discipline.* Have a good understanding of engineering and quality practices & methods.* Knowledge of ISO 13485, Good Manufacturing Practice (GMP), and Good Documentation Practice (GDP) requirements would be an advantage* Lean Six Sigma training a distinct advantage.* High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.* Experience in validation of processes.* Highly developed problem solving and strong analytical skills.* Excellent **English** and **Polish** (both oral and written)* Ability to be the voice of Quality when dealing cross functionally, will take the lead discussions / meetings to ensure the correct outcome.**Poland Pay Ranges:*** **Poland, Skawina**: 107.100 - 178.600 PLN gross annual At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.Travel Percentage: 10%