Stryker, a global leader in the medical technology industry, is looking for a talented Quality Engineer to join our New Product Introduction (NPI) team at our brand-new greenfield manufacturing site. This is a unique opportunity to contribute to life-saving innovations while ensuring the highest standards of quality and safety.
As a Quality Engineer in the NPI team, you will be at the forefront of ensuring that new products, processes, and technologies are developed and introduced with the highest levels of quality and compliance. You’ll work collaboratively with cross-functional teams, including Advanced Operations and Design Assurance, to execute project deliverables and support design transfer activities from concept through to production.
- Collaborative Quality Assurance: Foster strong professional relationships across Design Divisions, Advanced Operations, and GQO functions to ensure successful design transfer activities and achieve NPI project goals.
- Risk Management: Lead and support risk management activities, including the creation and maintenance of robust pFMEA processes. Ensure all risk management outputs comply with ISO 14971 and mitigate potential risks throughout the product lifecycle.
- Inspection and Validation: Develop and implement lean inspection strategies, lead First Article Inspection (FAI) strategies, and support the development and execution of validation protocols and reports. Aim for efficient, scalable, and repeatable inspection methods while minimizing human error.
- Process Excellence: Apply advanced statistical techniques and lean principles to develop robust quality systems. Provide expertise in process benchmarking, NCs & CAPAs, and Design for Manufacture and Assembly (DFMA).
- Supplier Quality Management: Support supplier qualification strategies, including supplier validations and Production Part Approval Process (PPAP). Ensure proper selection and certification of suppliers, and contribute to establishing Quality Agreements with Stryker sites and suppliers.
- Design Transfer: Represent Quality Assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring that all quality deliverables are met. Provide expert support post-launch and ensure the integrity of the process design through robust NPI quality deliverables.
- Degree in Engineering, Science, or a related discipline
- Proficiency in risk management, validation, metrology, and statistical techniques.
- Familiarity with medical device manufacturing processes, ISO 13485, QSR, GDP, GMP standards, and Lean Six Sigma principles is an asset.
- Strong analytical skills and ability to manage multiple projects simultaneously.
- Competency in complex problem-solving, process improvement, and design/process/technical issue resolution using tools like DMAIC.
- Excellent interpersonal and communication skills, both written and oral, with fluency in English and Polish.
- Desirable Skills:
- Experience with advanced product quality planning frameworks.
- Computer System validation experience.
At Stryker, we are driven by our mission to make healthcare better. As part of our NPI Quality Engineering team, you will have the chance to contribute to the launch of innovative medical devices that can transform lives. If you are passionate about quality, detail-oriented, and eager to work in a collaborative environment, we want to hear from you. Join us and be a part of something truly impactful!
This role is a fixed term role until February 2026.