Quality Assurance Specialist: New Product Introduction
1 miesiąc temu
About the Role:
Stryker, a global leader in the medical technology industry, is seeking a talented Quality Engineer to join our New Product Introduction (NPI) team at our manufacturing site. As a Quality Engineer, you will be responsible for ensuring that new products, processes, and technologies are developed and introduced with the highest levels of quality and compliance.
Key Responsibilities:
- Collaborate with cross-functional teams to execute project deliverables and support design transfer activities.
- Lead and support risk management activities, including the creation and maintenance of robust pFMEA processes.
- Develop and implement lean inspection strategies and support the development and execution of validation protocols and reports.
- Apply advanced statistical techniques and lean principles to develop robust quality systems.
- Support supplier qualification strategies and contribute to establishing Quality Agreements with Stryker sites and suppliers.
Requirements:
- 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.
About Stryker:
Stryker is a global leader in the medical technology industry, driven by our mission to make healthcare better. We are committed to developing 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.
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