Daily new jobs

The Company

Our partner is active in the development of highly innovative life-changing products.

Responsibilities

• Test method validations and process validations.
• Release of products for clinical studies.
• Review technical reports and design documentation.
• Manage structural improvements in the QMS. 
• Introduce and implement the quality processes and tools required to ensure product quality. 
• Provide training for relevant QMS Management areas.
• Manage and perform internal and external audits.

Requirements

• Minimum Bachelor Degree in technical area or other relevant scientific field.
• Minimum 5 years of industry experience.
• At least 2 years of experience in medical device
• Broad working knowledge of ISO 13485, ISO 14971, FDA QSR, EU MDD, EU MDR.
• Experience with test method validations and process validations.
• Experience in root cause analysis, corrective and preventive actions.
• Experience with risk management.
• Experience in writing and maintaining Quality Management System procedures,
• and providing training on them.
• Good knowledge of and experience with Quality Assurance & control methodologies.
• Experience with internal and external audits.
• Pragmatic approach to problem-solving.
• Able to work per priorities and tight deadlines in a fast paced, time sensitive environment.
• Good communication, reliable, independent, goal-oriented, pragmatic attitude.
• Strong organization skills.
• Fluent in English, reading and writing.
• Experience with statistical software, e.g. Minitab is preferred.