Stryker Project Quality Engineer New Product Introduction (18 months) in Cestas, United States
Your key responsibilities
While working with the local quality operations team, you are responsible for all quality related activities in the development and introduction of new Products, Processes and Technologies. You support the project team from a quality standpoint from Product Development into serial manufacturing. Within your project, you act as the main contact person for all project stakeholders and our international Advanced Operations and R&D teams.
As an experienced and assertive quality expert, you facilitate process validations, verifications, support process developments, manage NC/CAPAs to ensure a safe & efficient Design Transfer from initiation to close out including the Post-Market launch period.
You participate in internal and external audits with regulatory representatives and you coordinate trainings for Quality Engineers and related personnel on new quality systems.
As a quality project leader, you employ project management best practice to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
You enjoy working in a cross-functional & results oriented team environment where flexibility and effective communication is essential.
What are we looking for?
Master degree in an engineering discipline with 3 or more years’ experience in a technical role. Deep knowledge about manufacturing processes is mandatory.
You have knowledge in process validation, computer system validation, inspection strategies, project management and a good understanding of process optimization.
Experience in an FDA regulated or other regulated industry and familiarity with ISO 13485, GDP, GMP, process validation and risk management are beneficial.
You are an assertive, innovative, self-driven and open minded communicator with excellent interpersonal skills. As a team player, you can collaborate effectively with multidisciplinary teams. Your excellent analytical skills help you to organize.
High level of PC Skills (MS Excel, PowerPoint, MS Project) as well as high proficiency in statistical methods and applications are required.
Fluent in English and French is mandatory, German is an advantage.
Driving license recommended, as travel activities up to 30%.
Please notice that the title of this advertisement can differ from the position title.
Work From Home: No
Travel Percentage: Up to 25%
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com