**Vacancy Name**
- Design Quality Engineer
**Location of Work**
- Tijuana, Mexico
**Employment Type**
- Full Time Employee
**Our brand promise**
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.- **Remarkable service**
A seamless, personal process designed around you and your needs.
- ** Trusted performance**
Our product family is the result of years of experience championing surgeons and listening to their expertise.
- ** Outstanding value**
No matter the surgical specialty, we deliver quality products for all markets.
**Our people promise**
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
- **Job Purpose Summary**
As the **Design Quality Engineer**, you'll be responsible for developing and maintaining quality engineering methodologies in pursuit of delivering products that are safe and effective.
- **What you will do**
- Guide the quality assurance efforts in the design and development of technical transfers
- Appropriately document experiment plans and results, including protocol writing and reports
- Lead the investigation, resolution and prevention of product and process nonconformance's (e.g. CAPAs/HHEs)
- Participate in or lead teams in supporting quality disciplines, decisions, and practices
- Support design reviews and transfers, providing inputs on quality requirements, ensuring gap analysis and supporting risk mitigation strategies
- Adept knowledge on Medical Device waterfall gated process to be able to translate Customer/Market requirements (User Needs and intended use), Product Performance (Design Inputs, product requirements), Product Design (Design Outputs, device specifications, design specifications, design validations) and process Controls (Production and supplier controls).
- Provide guidance and support to other engineers to ensure quality integrity
- Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Work with design engineering in the completion of product verification and validation
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Design and conduct experiments for process optimization and/or improvement
**What you will need**
- Bachelor's degree in Engineering or equivalent education and experience
- 3+ years of experience working in a Design Quality Engineering role within a medical device industry
- Strong knowledge of quality management systems
- Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
- Strong Knowledge of statistical analysis tools and their use in product design and manufacturing.
- Six Sigma training is a must.
- Experience in creating design control documentation during the whole lifecycle of the development process
- Experience with previous transfer of products from design to volume manufacturing
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills
- Experience implementing various product and process improvement methodologies
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Fluent in Spanish and English required
**What we value**
- **Customer First** - We deliver extraordinary experiences.
- ** Accountability** - We do what we say.
- ** Integrity** - We do what is right.
- ** Inspired** - We love what we do.
- ** One Global Team** -We before me, always.
