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Quality Engineer
PresencialTiempo completoQA & Test AutomationMedical Devices
Support design control and project quality activities throughout the medical device product lifecycle. Coordinate compliance, risk management, verification, validation, change control, and quality documentation with cross-functional teams.
Responsabilidades
- Support and coordinate design control activities across the product lifecycle
- Maintain design planning, requirements traceability, verification, validation, design reviews, design transfer, risk management, and Design History File processes
- Coordinate quality planning and execution during engineering, procurement, and construction tender and project phases
- Verify contractual and regulatory requirements and customer quality requirements
- Establish project quality plans, witness points, and compliance records
- Identify quality gaps, resolve issues, and coordinate corrective actions with cross-functional teams
- Incorporate feedback of experience and lessons learned into proposals and execution processes
- Support design and document change control and product development activities
- Contribute to local improvement projects and global quality initiatives
Requisitos
- 3–5 years of quality engineering experience in the medical device industry
- Advanced experience in quality and QA engineering
- Knowledge comparable to a bachelor's degree or equivalent relevant experience
- Ability to analyze and resolve quality problems
- Ability to plan, document, and execute quality programs
Se valora
- Experience with product development lifecycles and design or document change control
- Knowledge of process verification and validation
- Knowledge of manufacturing and production process controls in a medical device environment
- Familiarity with quality management systems and continuous improvement methodologies
- Project management, negotiation, and conflict resolution skills
- Strong communication, collaboration, and prioritization skills
- Ability to communicate globally in English
Beneficios
- Total rewards package
- Career development opportunities
- Collaborative and supportive work culture
- No relocation assistance