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