Staff Validation Engineer role at Stryker
Contract role with full Stryker benefits. Member of the Global GQO-QA Validation team as Staff Validation Engineer. Support validation projects and initiatives as per business needs. Coaching and guiding multifunctional engineering teams to establish and meet the validation and process development corporate requirements. Responsible for local validation teams in terms of technical expertise and definition of best practices. High visibility and high-risk decision-making role. This is an individual contributor role that requires the use of judgment in applying professional expertise, and one is expected to work independently with minimal supervision.
Who we want
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize, and automate.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do
Work within the QA Global Validation Team, responsible for validation-related activities, including interpretation and guidance on regulations, corporate, divisional and site local procedures as they relate to validation activities.
Participate in the Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure current regulatory compliance and company objectives are maintained.
Participate in both Corporate and Local Validation Teams to discuss, provide feedback, and approve revisions to Validation Procedures.
Represent validation at internal and external audits.
Collaborate with cross-functional local and global teams; visit and work on manufacturing sites per project requirements on a hybrid basis.
Define validation strategies for highly complex validation projects (across multiple sites).
Ensure Validation Practitioners receive training and coaching to support and/or perform validations for current and anticipated projects.
Ensure appropriate systems are in place to evaluate changes to validated/qualified systems to maintain their validated/qualified state.
Apply quality engineering tools, statistical methods, design/development methods, process development/control methods, and process verification/validation planning to build quality into products.
Implement and develop Stryker's validation processes for newly acquired sites as part of M&A efforts.
Work closely with product transfer, NPI, NPD, and AO teams.
Lead validation continuous improvement projects.
Lead lean and Six Sigma initiatives on assigned projects and guide teams to apply these methodologies.
Serve as Subject Matter Expert for at least two validation specialties and be the primary support for those specialties (e.g., CSV, BFU, MSA, etc.).
What you will need
Proficiency in Medical Device Validation and QA.
Bachelor of Science in Engineering or related subject with 4+ years of experience in validation GMPs.
Understanding of engineering and machine tool fundamentals.
Self-starter with demonstrated efficient work methods, analytical and problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
Travel Percentage: 20%
This role will be posted for a minimum of 3 days.
Stryker is a global leader in medical technologies. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes.
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