Job Description
Celestica is a leader in high reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development.
Main Responsibilities
* Deliver fully automated high volume manufacturing lines from development stage to full scale production ramp producing world class medical devices in a dynamic, fast moving environment.
* Lead validation activities, process/procedure definition and maintain a continuous flow of high quality products to customers in a medical device environment.
* Support product families in the Med tech sector liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
Key Activities
* 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.
* 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.
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, 8 D 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.
About Celestica
Celestica enables the worlds best brands through our recognized customer-centric approach, partnering with leading companies in Aerospace and Defense, Communications, Enterprise, Health Tech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges.