Staff Quality Engineer

  • Cork
  • Stryker
Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: Position Summary:Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standardsPosition Requirements:​Will work within the Quality Operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:Work closely with Operations and the business functions to ensure quality performance of product and processes.Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.Lead and participate in the development of the internal Lab focusing on system performance and continuous improvement opportunities.Liaise with external Suppliers including external contract Lab ensuring best in class service and maintaining high quality performance.Review and approval of change management activities.Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.Proficiency in statistical methods and application.Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.Assist in the development, responsible for review & approval of process and equipment validation/qualification.Support manufacturing transfers to other plants/facilities, leading quality activities.Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.Coach and mentor others in quality topics and activities.Qualification/Skills Required:Bachelor degree in Science, Engineering or equivalent/ related subject and 4 or more years of work experience in a quality discipline.Previous experience in a Lab based environment desirable.Proficient in understanding of Med Device manufacturing processes desirable.Familiarity with ISO 13485, GDP, GMP desirable.Lean Six Sigma training a distinct advantage.Excellent communication skills and attention to detail.Have a good understanding of Quality and Lab practices & methods.High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.Must be willing to work as part of a multi-site team, with some travel required.Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.Highly developed problem solving and strong analytical skills.Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approachIs diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.Manages change well and adopts a continuous improvement orientation to the roleExcellent English (both oral and written)Ability to be the voice of Quality when dealing cross functionallyAbout StrykerStryker 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 130 million patients annually. More information is available at