Staff Quality Engineer - NPI

• Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partners
• Collaborative Partners. Relationship-savvy people who intentionally make connections, listen to others’ ideas and work together to move the business forward.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations

• Foster and lead collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Drive and lead effective communication with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
• Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.
• Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle
• Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.
• Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
• Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
• Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
• Support the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.
• Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
• Support device design into production specifications

• Bachelor of Science, Engineering or related subject with 4 years’ experience in a quality or technical discipline
• Masters of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline
• Familiarity with ISO 13485, QSR, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Working knowledge of Process Validation and Computer System validation
• Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
• Ability to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance.
• Must be able to generate, follow and explain detailed operating procedures (i.e. assembly instructions, inspection procedures etc).
• Experience in executing complex problem solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
• Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams. Open minded- able to recognize good ideas.
• Strong team player who effectively utilises individual strengths and talents to maximise team services to customers. Focuses on achievement of team objectives and team success.

Stryker