Who We Want
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers.
People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What You Will Do
- Provide support for quality issues resolution.
- 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 Teamwork 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.
What You Will Need
- Bachelor's degree in engineering;
- Experience in similar roll, including manufacturing environment required;
- ASQ CQE or six sigma GB certification preferred;
- Considerable knowledge of quality systems for medical devices;
- Proficient in MS Office Suite (including Word, Excel and Power Point);
- Intermedium English is required, Advanced English is a plus.
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.
Job Description The Equipment Maintenance Engineer will be based Tijuana. This position will be focused on: Through troubleshooting, identifies machine malfunctions and isolates the failure mecha [...]
Job Description The Supplier Quality Engineer will be based Tijuana. This position it will be focus on: Selecting the suitable supplier with jointed-effort of sourcing on aspects of quality, capabi [...]
Job Description - Manufacturing Engineer Project Leader (006EH1) Manufacturing Engineer Project Leader - 006EH1 Schneider Electric™ creates connected technologies that reshape industries, tran [...]
The Software Staff Engineer is a member of a couple of Software Development Scrum Teams. The role is of a Lead Developer who is motivated to actively contribute to the architecture, design and develop [...]