**Position summary** Provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards. **Key areas of responsibility** + Work closely with operations and the business functions to ensure quality performance of product and processes. + Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. + Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities. + Initiates and leads in the development and improvement of the manufacturing processes for existing products. + Oversight and leads investigations into Quality issues. + Review and approval of change management activities, challenges effectiveness and drives strong review. + Interpret KPI trends, drive continuous improvement process. + Subject matter expert in risk management practices and concepts. + Develop and provide input by identifying opportunities and weaknesses. + Proficiency in and provides technical direction in optimization of inspection methods and sampling. + High proficiency in statistical methods and application. + Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation. + Support manufacturing transfers to other plants/facilities, leading quality activities. + Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes. + Responsible for improvement within the electronic Quality Management System. + Coach and mentor others in quality topics and activities. **Education / work experience** + BS in a science, engineering or related discipline. + MS, CQE, or CRE preferred. + Six Sigma Green or Black belt preferred. + Minimum of 4 years experience required, 5 years preferred. **Knowledge / competencies** + Previous industry experience required. + Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired. + Understanding of US and International Medical Device Regulations. + Familiarity with ISO 13485, GDP, GMP required. + Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). + Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. + Ability to represent Quality function within and across project teams. + Strong interpersonal skills, written, oral communication and negotiations skills. + Strong in critical thinking and "outside the box" thinking. + Highly developed problem-solving skills. Strong analytical skills. + Demonstrated ability to successfully manage and complete projects in a matrix organization. + Demonstrated ability to work independently and as part of cross-functional teams. + Experience in working in a compliance risk situation. + Computer literacy. + Some travel may be required. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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.