Senior Quality Engineer in Tijuana bei Stryker Corporation

Datum der Veröffentlichung: 7/21/2019



1.- Purpose:

Responsible to improve and maintain the quality system through the development of assigned projects Main purpose of this position is to ensure the maintenance of the quality system to deliver only product that meets customer’s specifications and applicable regulatory requirements

2.- Main functions:Provide support for quality issues resolution. Maintain and updated quality system standard procedures because of continuous improvement activities, customer feedback, KPI’s trend analysis, and preventive and corrective actions Ensure the correct identification of product status, including non-conformance product segregation and identification through all the processes’ steps. Ensure process and product compliance to GMP and applicable regulatory requirements. Collaborate in internal audits of the quality system Lead or participate in Team work efforts to deploy and implement quality and process analysis tools or systems such as PFMEA, control plan, R&R, PDCA, RCA, SPC, Cpk. etc. Lead and Participate in quality system update and improvement projects Participate on the follow up and approval of product and process’s changes, IQ, OQ, PQ Collaborate in general in Continuous improvement activities Lead or participate in change control management meetings, including document control, master validation plans, NPI, etc. Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices Oversee inspection (examination) of incoming materials, ensuring that they meet requirements Lead the opening and closure of every single CAPAs stage, ensuring CAPA’s effectiveness and timing response fulfill CAPA procedure and applicable regulatory requirements

Quantity of direct reports, reporting to this position: n/a

Degree level: Bachelor degree, preference to industrial engineering or any other type of engineering degree

Experience: Minimum 5 years of experience in similar role or position.  Problem solving, Medical devices, ISO 13485, SPC, preference with a certification as ASQ QE, green belt, or black belt

Software: Windows, excel, minitab, and MRP software

English: Advanced

Work From Home: No

Travel Percentage: None

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