**This is a 23 month fixed term contract based in Carrigtwohill.** **Position Summary:** Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. 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. **General Requirements:** + 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 the project teams + Strong interpersonal skills, written, oral communication and negotiation 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 organisation + Demonstrated ability to work independently and as part of cross functional teams + Experience in working in a compliance risk situation + Previous industry experience required + Computer literacy + Some travel may be required **Key Areas of Responsibility** **:** + Work closely with operations and the business functions to ensure quality performance of product and processes + Collaborates with Divisional QA, cross functional and suppliers’ teams to address top quality issues + Own identified internal and supplier non-conformances and manage the timely closure of NC’s + Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure + Disposition non-conforming product within MRB, issuing NCs as appropriate + Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required + Engage in the development and improvement of internal manufacturing processes for existing products + Performs critical assessment of internal and supplier proposed change management activities + Performs PPAP activities for supplier changes + Participates and may lead in the creation and/or review of new or modified procedures + Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary + Support execution and analysis of manufacturing related complaints and product field actions + Support and drive Human factor practices, familiarity in the science of Human Factor identification, reduction and mitigation + Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification + Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations. + Support the creation and maintenance of inspection methods and sampling. + Applies statistical methods of analysis and process control to current operations. + Engage and interface in internal and external audits providing subject matter expertise + Support the development and review of process and equipment validation/qualification and MSA of internal processes. + Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. + Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities. + Responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes. + Drive continuous improvement actions to reduce manufacturing defects. + Provide leadership and subject matter expertise in QA activities to the overall site. **Qualifications** **:** + 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 preferred \#IJ Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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. 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.