- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
- Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
- Responsible to monitor and update on periodical basis the Quality key process indicators and to develop to achieve strategic goals and objectives, as well to identify and assure the implementation of corrective actions for quality issues.
- Maintain and update quality system standard procedures because of continuous improvement activities, customer feedback, KPI's trend analysis, and preventive and corrective actions Lead and participate on internal and external quality system audits.
- Ensure the correct identification of product status, including nonconformance 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 processes 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 CAPAs, ensuring CAPA's effectiveness and timing response for each of the CAPA's stages, and the fulfillment of CAPA procedure and applicable regulatory requirements as well.
- 3 to 5 years of experience in similar roll, including a minimum of five years in a manufacturing environment required.
- Medical Device manufacturing experience in a quality rol.
- ASQ CQEE or six sigma GB Certification preferred.
- Proficient in MS Office Suite (including Word, project, Excel, and Power Point, teams)
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Senior Quality Engineer - México, B.C. - Stryker Corporation
hace 4 días
Descripción
What you will do
The Senior Quality Engineer is responsible to establish, improve and maintain the quality system through the department 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.
What you need
