**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, MX
Applicants must be currently authorized to work in Mexico on a full-time basis.

📌 Quality Engineer Ii (Mexicali)
🏢 Breg
📍 Mexicali