Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

　　Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

　　Position requirements

　　Working in partnership with Global Supplier and Operations Network, this role is a Project Lead function that enables successful supplier changes and supplier projects by driving quality, cost transformation and service improvements for our customers whilst remaining compliant to both internal and external standards.

　　Position Requirements

　　Will work within the Shared Services Global Team, responsible for related activities as it applies to Supplier Initiate Change Request (SICRs) and supplier projects, these include but not limited to the following:

　　Support Organizational growth through demonstrating best in class Leadership ExpectationsCoach and develop team members building a strong technical support teamDevelop strong positive relationships with stakeholders to develop and maintain a best in class SICR programLead selected projects to deliver high quality outcome meeting all related metrics and key process indicators (KPIs)Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as PPAP, FMEA, MSA's, Validations and Qualifications. Reviewing and approving of Validation/Qualification DocumentationWorking with Subject Matter Experts, Consultants/Contractors, Suppliers, Divisional & Local resources as required ensuring that validations and change control activities are completed as per local, corporate, and divisional proceduresPoint of contact for SICRs in different GQO Manufacturing Sites and DivisionsEnable successful completion of SICRs and supplier projects to achieve its quality, cost and time requirementsBe able to identify SICRs quality risks/gaps and provide solutions to correctTechnical Quality Expert that sets strategy by utilizing a risk based approach around PPAP, FAI's, Inspection Certification, leveraging supplier testing, etc.Drive continuous optimization of SICRs ProcessCollect change requests from vendor and understand the status, priorities and assign for executionWork with Stryker Site team collecting inputs related to Specific SICRs, ECR generationCollaborate with vendor for getting the PPAP, MSA, GR&R & SICR activities in complianceSupport and participate in Supplier change review board [SCRB] and assist in decision making for type of changesConduct virtual audit and evaluation for Validation protocols & reports (IQ/OQ/PQ), Procedure changesEstablish and lead meetings with Stryker and suppliers for SICRs reviews

　　Qualification Knowledge Skills

　　FranceEngineering diploma (diplôme d'ingénieur) min of 8 years of work experience in validation and qualityMasters with min of 5 years of experiencePhD with min 3 years of experience desirableGermany / SwitzerlandBachelor of Science, Engineering or related subject and min of 8 years of experience in validation and quality, orMasters of Science, Engineering or related subject with min of 5 years of experience in qualityPhD with min of 3 years of experience desirableIrelandBachelor of Science, Engineering or related subject and min of 8 years of experience in validation and quality, orMasters of Science, Engineering or related subject with min of 5 years of experience in qualityPhD with min of 3 years of experience desirableNorth AmericaBachelor of Science, Engineering or related subject and min of 8 years of experience in validation and quality, orMasters of Science, Engineering or related subject with min of 5 years of experience in quality, orPhD with min of 3 years of experience desirable

　　Excellent communication skills and attention to detail.Have a good understanding of engineering and machine tool fundamentals.Strong knowledge of Quality Concepts and Risk Based Techniques (e.g. FMEA, Risk, Statistics).High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.Continuous Improvement MindsetLean Six Sigma training a distinct advantage.Must be willing to work as part of a multi-site team, be able to travel as part of the jobStrong project management skills. Must demonstrated success in tracking and reporting out progress against defined goals to project stakeholdersThe individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction

　　About Stryker

　　Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.

　　The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

　　More information is available at stryker.com