Design Quality Engineer

Design Quality Engineer
Req ID: 112932
Remote Position: Hybrid
Hiring Manager: Gonzalo Encinas Lajo
Band: 08
Region: Europe
Country: Spain
State/Province: La Pobla De Vallbona
City: Valencia

**Company: Celestica Valencia S.A.**

Celestica is a Canadian company, world leader in the electronic manufacturing sector. The plant in Valencia focuses its activities in the Aerospace, Industrial and Healthcare areas, producing and assembling high complexity products.

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 and medical device manufacturing services.

**Area/Department: Healthcare Quality department**

The Healthcare Quality department in Celestica Valencia is specialized in the assurance of the quality of design and manufacturing for current and new medical devices.

Customers go from worldwide multinationals to startups with innovative ideas.

The healthcare quality team is a young team in development with plenty of opportunities to grow.

**Description**:
Design Quality Engineer will be part of the development and quality assurance of new medical devices.

The role will engage with quality matters and will require the understanding of medical devices regulation (ISO13485 and FDA) - concept and feasibility to post market. Key lead in Design Quality related activities, but not limited to: generation and/or review/approval of product/validations/software/quality plans, design verification and validation, engineering studies, DHFs, DMRs, risk management, CAPA and complaint investigation coordination and execution, post market surveillance as well as change control management.

The role includes a full enrollment in the Design team and the New Product Introduction as well as coordination of engineering changes, coordination of work instructions and line support at product level along with good connection with other internal departments to review project/process/product transfer launch deliverables, validations, product specifications, and build-up of First Article Inspections.

The role may provide functional guidance to others performing similar work. May be considered the expert in areas assigned. Builds internal and external relationships that require exchanging information and providing guidance in a problem solving capacity.

**Knowledge/Skills/Competencies**:

- Fluent in English, spoken & written.
- Knowledge of medical devices design and development. Diagnostic devices desired.
- Knowledge of FDA QSRs, ISO 13485, ISO 14971, EU MDR/IVDR standards and regulations.
- Knowledge of quality, mechanical, electrical, electromechanical or bioengineering-biomedicine systems and principles of operations.
- Knowledge of quality standards and problem solving competency.
- Knowledge of QMS software systems and tools [e.g. root cause analysis (e.g. fault tree), statistical tools (e.g. Minitab)].
- Ability to effectively communicate with a variety of internal and external customers.
- Ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives.
- Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, and/or Certified Quality Auditor desired.

**Experience**:
3-4 Years of experience in Quality Assurance role in medical device industry, including Quality systems, standards, metrics, and tools. Diagnostic device industry experience desired.

3-4 years of hands-on in Design Verification, Design Validation, Process Validations, Change Control, Design History File (DHF), Device Master Record (DMR), and Risk Management (e.g. UFMEA, DFMEA, PFMEA, Plans, Reports, etc ) experience desired.

**Bachelor´s Degree**:
Bachelor’s degree in Engineering or associated fields in science, or equivalent, in medical and/or diagnostic device industry experience

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).

COMPANY OVERVIEW:
Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.

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