Quality Engineer
Celestica is a leader in high – reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development.
As a Quality Engineer at Celestica Galway (Ireland), you will be responsible for 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.
Key Responsibilities:
* 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 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.
Requirements:
* 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.
Preferred Qualifications:
* 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.