Senior Quality Engineer

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality practices

Root cause analysis

Statistical methods

Process validation

Risk management

Analytical thinking

English proficiency

Polish proficiency

Lean Six Sigma

Education

Bachelor of Science, Engineering or related subject

Job description

Work 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

Travel Percentage: 10%

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better.

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.