Quality Engineer Ii

hace 4 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.**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 keys 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.**What your background will be**:- 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 #2701, Pimsa IV Mexicali, MXApplicants must be currently authorized to work in Mexico on a full-time basis.

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