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Unlock the potential of the future @ Celestica
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. Celestica is a leader in high – reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development.
By Joining Celestica Galway (Ireland) as a Quality Engineer you will have the opportunity to work on delivering a fully automated high volume manufacturing line from development stage to full scale production ramp producing world class medical devices in a dynamic, fast moving environment. You will become responsible for dealing with the three major phases of Quality Management, Quality Planning/Prevention & Corrective Action.
Your next challenge will be…
To lead validation activities, process/procedure definition and maintain a continuous flow of high quality products to our customers in a medical device environment. This position will be responsible for supporting some of our product family in the Med tech sector liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
Your day to day activities will include the following…
* Provide expert QE technical direction/input to qualification and validation activities in conjunction with Design, Engineering and extended QA teams.
* Author and support (input and critical review) of qualification/validation protocols/reports.
* Lead the team to handle all quality excursions independently, and take effective actions on time
* Oversee the product ramp; material quality from NPI to mass production
* Develop the quality control plan for respective area (material/process/product)
* Monitor and report quality KPI for internal (factory) and external (customer)
* Drive continuous improvement to benefit customer, CLS and supplier.
* Develop and maintain internal quality system, procedures, work instructions and standards
* Coach / mentor staff members on quality topics to improve quality knowledge.
* Support the team and the organisational priorities in the quality deployment strategy.
* Work with supplier Engineering and help to address supplier quality issues.
* Take quality technical ownership for PFMEA’s in conjunction with process engineering
* Analyse data and provide real time feedback to ensure all manufacturing and process defects are detected and eliminated.
* Receive, process, manage, and investigate complaints including co-ordinating RMA’s as required and providing response to customer
* Be a leader in QSR, ISO / MDR standards within your group, be constantly aware of best industry practices.
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 success
* A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities
* A sustainable culture where we provide opportunities for employees to give back to the community
What do we expect from you?
* Strong knowledge of quality tools, QSR, ISO / MDR standards and processes
* A thorough working knowledge of Risk Management and Validation techniques
* Knowledge of statistical requirements and software validation requirements is an advantage.
* Strong knowledge of product and manufacturing processes and materials properties
* Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.
* Knowledge of Six sigma and Lean Kaizen.
* An ability to effectively communicate with a wide variety of internal and external customers
* Knowledge of the Medical Device industry or another highly regulated environment.
What are we looking for?
* A minimum of 4+ years Quality engineering experience is preferable
* Some materials engineering experience or quality materials testing knowledge is an advantage
* Someone with Med-tech experience
* Someone with an ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically and make sound decisions
* Experience of 6 Sigma quality methods would be a distinct advantage.
* Someone with a level 8 degree (240 credits) or equivalent in an Engineering or Science related discipline. However, postgraduate qualifications etc. will be considered if supported with relevant experience.
* Someone that is open to the opportunity of short term travel assignments particularly at the early stages of the project.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Manufacturing
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