Quality Assurance Specialist
hace 7 horas
Responsibilities:
* Determine and implement Quality Assurance procedures to ensure flawless execution of projects
* Collaborate with cross-functional teams to successfully implement quality improvement initiatives
* Conduct thorough audits and inspections to ensure compliance with industry standards and regulations
* Develop and maintain documentation of quality processes and procedures
* Analyze data and identify areas for improvement to optimize operational efficiency
* Train and educate team members on quality standards and effective strategies
* Maintain the Quality Management System (QMS) as directed by the Quality Assurance at HQ, and the support of the Technical Director. Ensures that PDX Spain and Portugal QMS conforms to customer, internal and local regulatory/legal requirements
* Act as the Quality Management Representative / Subsidiary Quality management Representative for the company
* Approves and monitors entries in the Nonconformance, Corrective Action/Preventive Action and training systems
Requirements:
* Bachelor's degree in Life Sciences or a related field, or equivalent experience
* Proven experience in quality assurance
* Knowledge of Quality Management System requirements, especially with regard to European regulations (21 CFR Part 820, ISO13485/ IVDR and ISO9001 requirements)
* Experience in medical device industry/Life Sciences industry experience preferred
* This position would require up to 20% domestic and international travel
* Strong understanding of Quality Assurance methodologies and tools
* Excellent analytical and problem-solving skills
* Exceptional attention to detail and a commitment to delivering world-class results
* Ability to work collaboratively in a fast-paced, ambitious environment
Thermo Fisher Scientific Inc. is an equal opportunity employer and is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance or an accommodation during the application process, please contact us.
Apply today to start your journey with Thermo Fisher Scientific Inc. and be part of our mission to accelerate research, drive innovation, and make a positive impact on the world.
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