Staff Engineer, Validation

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

RESPONSIBILITY

What you will do as Staff Engineer Validation includes:

• Is actively involved in the development of Stryker's validation strategy, consisting of the Corporate Validation Procedure and the related work instructions.
• Supports the definition of validation strategies for highly complex validation projects (multiple entities or multiple sites).
• Review/Approval of relevant validation deliverables, as required, as Validation Representative.
• Maintains and delivers training modules for the training of the Corporate Validation Procedure, the related work instructions and ValGenesis.
• Drives due diligence activities related to validation.
• Coordinates Validation Certification of Engineers.
• Supports internal, corporate, and external audit, if required.
• Acts as Subject Matter Expert for at least two special validation skillsets (e.g. Computer System Validation (CSV) / Qualification of Buildings, Facilities and Utilities (BFU) / Analytical Test Methods (ATM)).
• Leads at least one Corporate Validation SME group in the global Validation Hub
• Spoke team to improve and develop Stryker's validation program.
• Acts as local Site Administrator in Stryker's electronic Validation Lifecycle Management System (eVLMS) ValGenesis for several sites.
• Contributes to the development of ValGenesis.
• Act as coach for junior team members.

QUALIFICATIONS

• Bachelor of Science, Engineering, or related subject with 6 years of experience in validation.
• Medical devices experience.
• Experience working in highly regulated manufacturing industry.
• Must be fluent in Polish and English
• Excellent communication skills

About Stryker
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 130 million patients annually. More information is available at stryker.com.