Senior Quality Engineer

Stryker; Skawina; On-site; PLN 107,000 - 179,000; Full time

Job summary

Stryker Poland in Skawina is seeking a Quality Engineer to partner with manufacturing and cross-functional teams to improve product and process quality, drive corrective actions, and lead audits.

You will apply risk-based methods, manage change control, and support process validation and product transfers across facilities, while communicating in English and Polish.

Qualifications

• Bachelor of Science in Engineering or related field with minimum 2 years in quality discipline.
• Strong understanding of engineering and quality practices/methods.

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 actions, 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.

Skills

Quality engineering

Root cause analysis

Statistical methods

Process validation

Risk management

Audits

Lean Six Sigma

English and Polish

Education

Bachelor's degree in Engineering or related

Job description

• Poland, Skawina: zł107.100 - zł178.600 PLN Annual

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

W Stryker wierzymy, że przejrzystość pomaga kandydatom podejmować świadome decyzje dotyczące kolejnego kroku w ich karierze zawodowej. Wynagrodzenie jest ważnym elementem tego procesu i chcemy jasno wyjaśnić, w jaki sposób jest ono ustalane. Informacje dotyczące wynagrodzenia publikowane dla tego stanowiska mogą być przedstawione jako przedział wynagrodzenia lub jako stała kwota - w zależności od roli. Oprócz wynagrodzenia podstawowego stanowisko to może kwalifikować się do dodatkowego wynagrodzenia motywacyjnego (takiego jak premie i/lub prowizje, jeśli mają zastosowanie), a także do kompleksowego pakietu świadczeń oferowanych przez Stryker.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.