Subject Matter Expert serving as core Operations Quality Engineer for new and current products while applying comprehensive knowledge of lean six sigma and quality engineering principles, six sigma black belt, design for manufacturability (DFM) and problem solving (RCA) techniques to ensure the highest level of product quality. **Responsibilities:** + Lead in cross-functional teams to ensure process qualification/validation methods are aligned with industry best practices and applicable standards. + Work with Operations to ensure the optimization of manufacturing processes using engineering principles such as Six Sigma and Lean methods. + Lead investigations of product quality and compliance issues related to NCRs and CAPAs including analyzing results and making recommendations. + Recommend test methods and statistical process control (SPC) for achieving required level of product quality. + Represent Operations Quality Engineering during the design transfer process for R&D programs. + Develop and coordinate technical studies and design of experiments (DOE) as necessary to improve product quality. + Develop statistical models to identify products or processes posing excessive failure risks. + Propose improvements as necessary in process design and process controls to achieve a high level of product quality and process yield. + Develop technical content of risk management files related to Operations. + Review engineering change orders for impact on specifications, product quality, and compliance. + Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. + Conduct supplier process audits and support activities to resolve audit findings. + Support all initiatives as identified by management in improving Quality Management Systems (QMS) and other regulatory requirements. + Mentor and Provide Guidance to Junior Engineers on RCA, and Operational best practices + Support and Partner with counterparts for continuous improvement efforts, especially for new equipment or improved processes. + Perform special projects as assigned. **Qualifications:** + Bachelor’s degree in Engineering or Technical field. + Prior medical device manufacturing and quality engineering experience. + Thorough knowledge of advanced statistics and problem-solving techniques. + Strong Track Record working in Operations Environment on Day-to-Day activities + Minimum 10 years’ experience in product realization in medical devices. + Excellent verbal and written communication skills. + Detail oriented; deliver high quality product consistently and on time. + Thrive in a fast-paced and dynamic work environment. + Computer skills including statistical/data analysis and report writing skills. Certification in Six Sigma Black Belt / ASQ certification preferred. $ **115,600** - **$** **245,800** salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. 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.