Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Responsibilities:

• Be responsible for, handle, and continuously improve the NCM/Deviation system
• Have authority to approve NCMs/Deviations/CAPAs
• Conduct internal and supplier audits
• Final review of the device history record and product release for shipment to Hennigsdorf
• Review and approval of quality documents and records
• Provide quality input into development projects under design control
• Continuous improvement of quality assurance related processes
• Create and lead measurable benchmarks to ensure ongoing monitoring of QA processes
• Be the deputy for all quality assurance related activities

Requirements:

• Bachelor's degree in Engineering or a related field
• Demonstrated ability in quality assurance
• Outstanding self-motivation and ability to collaborate optimally
• Teamwork and communication skills
• High degree of result and solution orientation
• High degree of energy
• Very good knowledge of ISO 13485, 21 CFR 820, Root cause investigation techniques
• Ability to work internationally
• Proficient in English and French, technical writing skills for quality documentation and records, proficient with Microsoft word, excel and power point.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.