Design Quality Assurance Engineer

hace 3 semanas

Valencia, España Celestica A tiempo completo

Req ID: 117409
Remote Position: Hybrid
Region: Europe
Country: Spain
State/Province: La Pobla De Vallbona
City: Valencia

**General Overview**:
**Summary**:
**Your new challenge**:
Take your next career step on by joining Celestica as Design Quality Engineer into a multinational company world leader in electronic manufacturing.

You challenge will be connected with the creation from conception, design, build and debug of new products and systems verification for different sectors: health-tech, aerospace and defense, smart energy and industry as our corporate design team is energizing the transformation of society and industry to achieve a more productive and sustainable future.

**Your day
- to-day activities will include**

You will be responsible for quality assurance of the design of the different products that our development teams bring to life; from architecture to electronic circuits design and analysis, verification, validation and transfer into manufacturing. The whole design lifecycle.

With this opportunity, you will become one of the key members of our development team, bringing value from your experience, proposing solutions and alternatives aimed to overcome different design challenges across multifunctional development projects and gathering the opportunity to grow and unlock all your potential.

**Detailed Description**:

- Guide the quality assurance efforts during the design and development phase of new electronic products, ensuring compliance with industry standards, regulations, and customer requirements for the different projects in the Design and Engineering Services Group. Supervising all Quality design activities, review of deviations and design controls. Monitoring the Product Requirements and traceability throughout the development lifecycle
- Support and collaborate in the creation and approval flow for design documents, like DIOVV trace, (design input, output, verification & validation), DFMEA, drawings, V&V protocols and reports, design review, rationales. Create /update and review product risk management documents (Hazard analysis, DFMEA, RMP, RMR, ) in accordance with ISO 14971.Conduct RCA and structured problem solving (CAPA). Design Controls in compliance with 21 CFR 820, ISO 13485, ISO 9001, ISO9100. Compliance Gap analysis. Support design reviews and design transfers providing inputs on quality and requirements.
- Attend and support internal and external Design Audits. Provide guidance and support to other engineers, sharing best practices and fostering a culture of quality throughout the organization. Support and collaborate in the creation of quality plans, inspection criteria and risk mitigation strategies. Statistical Analysis (SPC, cpk, ppk, normality) Support and collaborate in the creation of master validation plans and reports IQ, OQ, PQ. Support the submissions to FDA 510K and CE Marking (EU MDR). Collaborate with suppliers to drive quality improvements, and ensure compliance with quality standards and specifications.

**Knowledge/Skills/Competencies**:

- Proven experience on product development environment. specifically in the medical/healthcare arena. Solid understanding of electronic product development processes, including design controls, design verification, and validation. Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) Expertise in conducting risk assessments, failure analysis, and root cause investigations using tools and methodologies such as FMEA, DOE, and 8D.
- Knowledge on statistical analysis tools
- Cross-functional coordination abilities. Getting things done.
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced, deadline-driven environment.
- Project management skills and experience is an asset. Fluent in English, both written and oral. Team-building attitude

**Typical Experience**:

- 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
- Experience with PDM tools and Requirement capture and traceability tools in an asset.

**Typical Education**:

- Bachelor’s degree or Master of Science in engineering
- Strong knowledge of quality management systems, industry standards (such as ISO 9001, ISO 13485), and regulatory requirements (such as FDA, MDR, RoHS, REACH).

**Notes**:
**What about your new team?**

The Design and Engineering Services department in Celestica Valencia is specialized in the development of new products and electronic systems for both its customers (mostly international) and the production line within the factory.

The main differentiator in Valencia facilities are its design capabilities and the various engineering services that it can provide to its customers, creating a differential value beyond the regular electronic manufacturing

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