Senior Quality Engineer

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

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: zł107.100 - zł178.600 PLN 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.

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

Work Flexibility 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.