Senior Quality Engineer

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

Job summary

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

Strong analytical and problem solving skills are essential. The role requires a Bachelor’s degree in engineering or related field, at least two years in quality, and knowledge of ISO 13485, GMP,

Qualifications

• Bachelor’s degree in engineering or related field with 2+ years in quality discipline.
• Knowledge of ISO 13485, GMP, GDP advantageous.
• Lean Six Sigma training advantageous.
• Strong problem solving and analytical skills.

Responsibilities

• Partner with manufacturing to improve product and process quality performance and lead preventive quality activities.
• Lead and support nonconformance and CAPA activities, including root cause analysis and corrective actions.
• Drive continuous improvement by analyzing quality metrics and implementing actions.
• Review and challenge change management for robust quality and process effectiveness.
• Lead quality activities for manufacturing process development, validation, and transfers.
• Apply risk management to identify process risks and mitigation strategies.
• Optimize inspection, sampling, and process monitoring for QA effectiveness.
• Support internal and external audits and interact with regulatory authorities.

Skills

Problem solving

Analytical thinking

English proficiency

Polish proficiency

Quality systems knowledge

Education

Bachelor of Science in Engineering

Job description

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

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.

Jeśli chcesz dowiedzieć się więcej o wynagrodzeniu lub benefitach związanych z tym stanowiskiem, rekruter chętnie omówi szczegóły na kolejnych etapach procesu rekrutacyjnego.

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.