Work Schedule
7 1/2 hr shift

Environmental Conditions
Office

Job Description

Thermo Fisher Scientific Inc. is seeking a highly skilled and experienced Quality Specialist I to join our world-class team. As a Quality assurance specialist, you will play a critical role in ensuring the flawless quality of our products by collaborating closely with internal teams in Spain and Portugal and with PDX Quality. This is an exceptional opportunity to showcase your proven expertise in supplier quality management and make a significant impact in a leading scientific company.

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.

• 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