Work Flexibility: Hybrid or OnsiteWho we wantDedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.User-focused creators. People who imagine with the user in mind, developing technology that helps change patients' lives.What you will doA Senior Quality Engineer will provide support and direction in quality assurance, control and preventative activities with a focus on sustaining products. Manages the execution and changes in quality activities for internal and external suppliers related to process development, verification, validation and product transfer while ensuring compliance to regulations and standards.Works closely with operations and the business functions to ensure quality performance of product and processes.Collaborates with Divisional QA, cross-functional, shared services and supplier's teams to address top quality issues.Participates in creation and/or review of new or modified procedures. Executes PPAP activities for supplier changes.Leads the development of process and equipment validation/qualification and MSAsAdvocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.Applies statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes.Serves as the GQO Quality representative on cross functional project teams.Critical assessment of internal and supplier proposed change management activities.Develops understanding of risk management practices and concepts and applies knowledge to manufacturing operations.Leads internal and supplier driven non-conformances and manage the timely closure of NC's.Ownership of GQO Quality process areas.Leads CAPA projects and manage to timely root cause investigation, implementation and closure. Performs as subject matter expert for internal and external audits by regulatory agencies, notified bodies, competent authorities, etc.Leads quality system projects of a moderate scope and complexity.Dispositions non-conforming product within the material review board (MRB), issuing NC's as appropriate.Maintains KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.Collaborates with appropriate stakeholders to identify and execute opportunities for supplier part certification as required.Supports the creation and maintenance of inspection methods and sampling.Supports the development and improvement of the manufacturing processes for existing products.Leads execution and analysis of manufacturing related complaints and product field actions.Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. Supports manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.Reviews and approves equipment, process, MSA and software validation protocols and reports.Collaborates with Regulatory to execute the creation and revisions of Instructions for Use (IFUs).What you needRequiredBachelor's degree required2+ years' experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.Knowledge of Quality Concepts (eg Risk Management, CAPA, Audits, Statistics).PreferredBachelor's degree degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended.Professional certification in a quality subject matter (eg, MS, CQE, CRE, Six Sigma) highly desirable.Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environmentKnowledge of applicable regulatory requirements (ISO 13485, FDA Quality System Regulation, European Medical Device Regulations, etc.) desired.Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc).Formal investigation and root cause skills preferred.Ability to read and interpret engineering drawings and other technical specifications preferredProject management skills and ability to influence without authority.Preferred industries are medical device, aviation, aerospace, automotive and defenseTravel Percentage: 10%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 contractor's legal duty to furnish information.