Quality Engineer II
hace 7 meses
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 busy… you 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 specificationsEnsuring project compliance to internal and external standardsCoordinating risk analysis activitiesCreating and managing the Quality Engineering deliverablesOwning and driving Corrective and Preventative actionsGenerating/coordinating verification and validation test activities, acceptance criteria and sampling sizes Develops and implements robust measurement systems through application of tools such as Measurement System Analysis (MSA). 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 Must have risk management experience including generating risk analysis and applying the concepts and principles of ISO 14971. 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, MX
Applicants must be currently authorized to work in Mexico on a full-time basis.
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