Design Quality Engineer - South Dublin.In this role you will be representing WorldWide Quality on medium to high complexity new product development and/or the life cycle management/sustaining engineering roadmap.As a Quality Leader in the Core Team, you will develop and drive the quality plans to secure program success and its contribution to Quality and Business strategy. Manage/influence extended quality SME's.As a Quality Engineering expert, you will master a wide range of quality engineering processes and methodologies. Apply extensive design control expertise, problem-solving approaches and analytical skills to secure impactful product and technology roadmap outcomes.In addition, this position plays an active role in the processes to ensure products meet customer/patient needs and quality standards consistently with both corporate and unit policies, while meeting all design control and other regulatory applicable requirements.This role is to serve as an expert in design control and best practices for electro-mechanical devices with software.Main responsibilities will include:Translates project and quality/business strategies into achievable Quality Plans embracing all Quality Engineering activities, including but not limited to: risk management, process validation & control strategies from raw material to commercial product. Engages the Platform/Segment into this strategic directionDetermine how to use available resources to meet schedules and goalsEnsure design control activities are satisfied in effective and efficient mannerLead product related risk management activitiesEnsure worldwide validation plans related to the product/process design are established consistently with business strategy, and process validation activities are completed right the 1st time.Support supplier qualification strategy and plansSupport appropriated robustness of test methods used in project activities (test method validation or equivalent when used in different sites)Define the product & process WW control strategy, integrating past learnings and operational strategiesRelease product under developmentEnsure quality conduct of project, including design, data summary, interpretation and report generation. Identifies any issues that may delay product or project and recommends appropriate action to be takenDrive of quality functional reviews at key points and upon completionAssist/conduct complex failure investigations and problem-solving sessions for non-conforming products.Develop solutions to complex problems which often requires the regular use of ingenuity and creativityReview Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.Liaise with Manufacturing Plants and SMOProvide technical direction and support to the extended quality team members. Actively coaches/mentors them and provide frequent feedback.Participates and assists in the team’s success, continuing to set a higher standard on technical skills and helps associates rise to expectations and advise management of technical needs and desired skill mix.Provide Quality Engineering guidance and support to internal organisations, regulatory bodies, and customersEnsure product compliance and implementation of global procedures and standards for assigned Quality Engineering responsibilities.Interested applicants should have a degree or master’s degree in quality management, engineering, science, or similar.At least 10 years’ relevant experience, in a regulated industrial environment.Medical Device experience, especially with electromechanical devices, is required.Detailed understanding of industry regulations/standards: ISO 13485, QSR, GMP, ISO 14971, ISO 62304, IEC 60601Extensive knowledge and expertise of design control principles, risk analysis and change control.Significant complex-level engineering, new product development experienceRecognisable outstanding technical qualifications and leadershipExhibit knowledge and experience of statistical techniques of growing complexity, quantitative and qualitative, to facilitate design and process analysis, including improvements (Reliability Engineering, DMAIC, or Lean)Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.Demonstrative knowledge of inspection methods and sampling techniques as well as a proficiency in test method validationAble to communicate effectively at all levels within Quality as well as multi-functionally with departments such as R&D, Regulatory, Manufacturing, and MarketingKnowledge and experience in manufacturingTrack record of problem solving and analytical skills to support recommendations/decisions.Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.Ability to handle multiple product & process design related projects, from product inception through product launch and maintenance in an unsupervised environment.Good written and oral communication skills including in English language.
