Senior Staff QE

Participating in the definition of the Stryker validation strategy to be outlined in Corporate procedures and based on regulatory requirements. Responsible for local validation teams in terms of technical expertise and definition of best practices. Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sites. Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices. Will work within the QA group, responsible for validation related activities, including, but not limited to the following:

• Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
• Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
• Being Subject Matter Expert in more than 1 validation specialty for development of Corporate Procedures and Work Instructions.
• Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
• Representing validation at both internal and external audits.
• Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
• Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
• Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
• Reviewing and approving of Validation/Qualification Documentation.
• Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
• Mentoring for Graduate Validation Engineers
• Establish Validation standards in terms of Industry Best Practices and drive this level across the organization

• Bachelor of Science, Engineering or related subject and 6 plus years of experience in Quality/validation.

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