Specialist, Operations Quality

Summary:A career at Celestica is only for those who want to do something extraordinary with a meaningful purpose: imagine, develop and deliver a better future with our customers.By Joining Celestica Galway (Ireland) as a Quality Engineer you will have the opportunity to work with an incredible team taking on the amazing challenge of becoming an emerging leader in the introduction of new Medical Device products. You will become responsible for dealing with the three major phases of Quality Management, Quality Planning/Prevention, Corrective Action.Your next challenge will be…Lead process/procedure definition and maintain a continuous flow of high-quality products to our customers in a contract manufacturing environment including regulatory content for the latest and more innovative medical devices. This position will be responsible for supporting some of our product family in both the Med tech and Industrial sectors liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.Your day- to-day activities will include:• Mentors and develop personnel in the practices of Quality management and Quality improvement• Lead the team to investigate any quality excursions and implement corrections and corrective actions• Lead the quality group in a fast-paced production environment• Customer liaison for quality escalations and daily quality issues ensuring measured, developed and timely responses to the customer.• Support the change management process and Customer requests as appropriate.• High level of competence using relevant corrective action systems (e.g CAPA)• Create concise and accurate technical reports, communicate results and manage subsequent analysis queries• Continually seek to drive improvements in product and process quality.• Create and evaluate metrics to drive the quality improvement processes.• Own, Maintain and report timely and accurate KPI’s• Manage and maintain the NCMR database and report weekly to the customer.• Using appropriate statistical techniques to monitor process performance (e.g.SPC, Minitab, Ppk, Gage R & R analysis, sampling techniques).• Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg. FMEA’s, control plans).• Apply project management skills and methodology as necessary for key CI projects.What do we expect from you?Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485)Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format.Strong knowledge of product and manufacturing processes and materials propertiesKnowledge and understanding of the manufacturing environment and how decisions impact customer satisfaction product quality, on-time delivery and profitability of the unitKnowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.Knowledge of Six sigma and Lean Kaizen.Ability to effectively communicate with a wide variety of internal and external customers to summarize complex technical issuesKnowledge of Med-tech and regulatory requirements (such as FDA and MDR) is a requirement of the role withpharma & medical device systems an advantageAbility to effectively lead and manage several projects simultaneously and coordinate multiple, changing deadlines while also working effectively on their own and in a team environment.Ability to be an Internal AuditorWhat are we looking for?Experience in a Med-tech environment is essentialExperience of 6 Sigma quality methods would be a distinct advantage.Materials engineering experience/quality materials testing knowledge is an advantageExperience of leading a team is an advantage.What do we offer?Market-competitive total reward: flexible salary, fix and variable salary based on goals;The opportunity to become a key member of the new product introduction team in the Health Tech.Quality function driven by innovation where creativity matters;Training and development opportunities, with us the sky is the limit;The opportunity to innovate, learn, mentor others and work toward your own vision of career successA global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunitiesA sustainable culture where we provide opportunities for employees to give back to the communityPhysical Demands:Sitting/standing, free to move aroundWalkingSustained visual concentration on small areas, such as monitors, screensThe job works in generally good conditions with occasional exposure (10% - 33%) to noise, odours, dust, drafts, chemicals, operating machinery, temperature extremes, hazardous substances, etc.Occasional overnight travel is required.Typical Experience:4 years experience in a quality role within Health Tech manufacturing environmentTypical EducationBachelor's degree in related field