We seek to incorporate a Quality Engineer for a vacancy in the Quality Management Department of B.Braun Surgical, S.A. from Monday to Friday.
Functions :
* Leads or supports quality standards for the production line (components and processes) and suggests modifications meant to prevent defects in final product.
* Works closely with cross-functional teams, including product design, product management and operations, to identify and mitigate quality risks.
* Leads quality initiatives and continuous improvement activities.
* Audits production processes, raw materials or suppliers / vendors to ensure that established quality standards are met.
* Supports Supplier Quality in monitoring supplier performance.
* Leads or supports root cause analysis for defects, non-conformities or other quality failures.
* Reviews and approves product / process specification and procedures, as well as deviations documentation.
* Develops Quality and Sampling Plans as needed.
* Supports product and process validation activities.
* Acquires and analyzes data using appropriate quantitative methods to facilitate process analysis and improvements.
* Supports organization in terms of Statistics and process controls.
* Uses problem solving techniques to conduct complaint investigation, root cause analysis, CAPA, and quality improvement when necessary.
* Ensures compliance of the assigned processes with formal external quality standards applicable to Manufacturing of Medical Devices
* Other duties may be assigned
Requirements :
* BS in Engineering preferred.
* 4+ years Quality Engineering experience with a Medical Device Company required.
* Must have understanding of ISO13485, FDA QSRs and ISO14971.
* Proficient in the use of Microsoft Excel, Power Point and Word.
* Use of Minitab and other statistical tools.
* Requires good written and interpersonal communication skills in English.
* Process experience in sterilization processes preferred.
* Knowledge of statistics and process controls preferred.
* Six Sigma and Lean methodology training / experience preferred.
* Position located Rubi. Must be able to travel.
* Works well in a team environment with limited supervision.
* Analytical Skills and Pays attention to detail is required.
If you believe your experience and professional interests are align with the offer, I encourage you to apply!
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