Quality Engineer Ii

hace 2 semanas

Mexicali, México Breg, Inc. A tiempo completo

Are you looking for an exciting opportunity? We currently have a full‑time opening for a Quality Engineer II in our Mexicali, MX office. If you are looking for a fast‑paced environment where you can make a difference every day, then this is the opportunity for you The right person to join our team is. Demonstrates ownership and accountability; demonstrates the ability to: plan, execute, control and deliver; communicate effectively both written and verbal; lead and influence others effectively. This position is responsible for. The Quality Engineer II is responsible for providing Quality support for new products and product improvements from concept through design and validation and into production through stable operations. S/he is also required to support manufacturing in resolving issues for both new and established products. Responsibilities Your day will be very busyyou will: Participates in cross‑functional project teams to support new product development and quality improvements. Leads investigation, corrective/preventive action and implementation of quality improvements. Manages the Supplier Quality program; participates in selection and qualification of new suppliers, manages the supplier audit program and supplier corrective actions. Manages supplier quality controls and implements supplier improvement strategies. Provides guidance and assistance to engineering during all phases of new product development and manufacturing including design and document reviews, risk assessment, hazard analysis, problem solving, verification and validation. Performs technical reviews and/or develops key documents including quality and reliability plans, FMEA, product and process validation plans & reports, and sample size justification. Provides Quality Engineering project support throughout the product development lifecycle, including but not limited to: Assisting with the development of product requirements and specifications Ensuring project compliance to internal and external standards Coordinating risk analysis activities Creating and managing the Quality Engineering deliverables Owning and driving Corrective and Preventative actions Generating/coordinating verification and validation test activities, acceptance criteria and sampling sizes Serves as the Quality focal point for the project team and the customer on all items related to safety and regulatory compliance, as well as compliance with all Breg procedures. Qualifications BS degree in a scientific discipline with 2‑5 years related medical device experience or MS degree in a scientific discipline with 2+ years related experience or equivalent combination of education and experience. ASQ (CQE, CRE, CQA, etc.) certifications desired. Experience with electromechanical devices preferred. Must have proven experience with FDA audits or regulated body audits such as ISO. Lean Manufacturing and Project Management experience preferred. Must be proficient in validation and evaluation methods. Work Schedule: Monday to Friday from 7:00 am to 5:00 pm Work Location: Circulo de la amistad #****, Pimsa IV Mexicali, MX Applicants must be currently authorized to work in Mexico on a full‑time basis. #J-18808-Ljbffr

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