Senior Engineer, Advanced Quality Engineering at Stryker

Work Flexibility: Hybrid or OnsiteSenior Engineer Advanced Quality EngineeringStryker is hiring a Senior Engineer Advanced Quality for our Sustainability Solutions team supporting our reprocessing product this role youll be part of a team that ensures innovative medical devices are safe effective and compliant. Youll collaborate across R&D Regulatory Affairs and Operations to deliver products that improve patient outcomes worldwide. If youre passionate about quality and innovation this is your chance to make a real impact.Work Flexibility:Hybrid; must reside within a commutable distance to Tempe AZ and be onsite at least 3 days per week.What You Will DoRepresent Quality Assurance on cross-functional New Product Development teams to meet project milestones.Lead Risk Management activities including creating and maintaining Risk Management Files and ensuring compliance with design control procedures.Plan design and implement inspection and testing methods using advanced statistical techniques to ensure product reliability.Conduct and lead Design Reviews to confirm design robustness and regulatory compliance (QSR ISO 13485).Perform and review engineering risk analyses test methods and process improvements to enhance quality and efficiency.Guide product development by interpreting test data and developing protocols for processes and products.Mentor junior team members and lead departmental initiatives to drive quality and compliance.Collaborate with internal teams and customers to address product quality concerns and support continuous improvement.What You Will NeedRequired QualificationsBachelors degree in Mechanical Electrical Chemical Material Science Biomedical Engineering or related field2 years of experience in an engineering role.Experience in data collection data analysis and applying scientific methods.Preferred QualificationsExperience with Quality concepts such as Risk Management CAPA Audits and Statistics.Previous experience in the medical device industry.Knowledge of U.S. and international medical device regulations including ISO 13485 GDP and GMP.Six Sigma Green Belt or ASQ Certified Quality Engineer (CQE).Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:Senior IC Key Skills Quality Assurance,Six Sigma,Design Controls,FDA Regulations,ISO 9001,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing Employment Type : Full-Time Experience: years Vacancy: 1