Validation Engineer 100%

About the job

Technology, quality and regulatory requirements are inseparably linked for you? Then apply now in Basel as

Validation Engineer 100%

Your area of responsibility

• Overall responsibility for the establishment, implementation and further development of process validations according to international standards (ISO 13485, MDR, QSR)
• Planning, execution and maintenance of cleaning, packaging and sterilisation validations etc.
• Planning and support for machine and equipment qualifications as well as cleanroom qualifications according to ISO 14644
• Creation and approval of validation and qualification plans as well as reports (internal and external)
• Creation of key figures and application of statistical methods
• Support of changes and design transfers in new developments and process adjustments
• Participation in risk analyses (e.g. FMEA)
• Technical responsibility for the transfer of validation activities
• Participation in and execution of internal and external audits
• Development and implementation of training courses
• Leadership and participation in quality-relevant projects
• Ensuring compliance with GMP principles and occupational safety regulations

Your qualifications

• Completed studies (BSc/MSc) in engineering or a comparable technical education
• Several years of experience (at least 3 years) in quality management and process validation in medical technology, ideally including equipment and machine qualification
• Sound knowledge of relevant regulations and standards (ISO 13485, MDR 2017/745, QSR, 21 CFR 820.75, Swiss Therapeutic Products Act) as well as practical experience in their implementation
• Experience in planning, execution and documentation of validations, complemented by know-how in statistical methods (e.g. Six Sigma Green Belt) and risk analyses (e.g. FMEA)
• Confident handling of MS Office as well as common ERP and quality systems (SAP, PLM, CAQ)
• Very good German and English skills
• Independent, structured and proactive personality with pronounced analytical skills, strong communication skills as well as networked and process-oriented thinking and the ability to convey complex matters appropriately to the target group.

What we offerWe offer you a responsible and varied activity with high quality requirements in a growing, international company with progressive social benefits.

About MedartisAt Medartis, we combine innovative solutions with qualified specialists to be the preferred provider in orthopaedics. The Medartis Group was founded in 1997 and is headquartered in Basel, Switzerland. It is one of the world’s leading manufacturers and suppliers of medical technology for the surgical treatment of bone fractures of the upper and lower extremities as well as in the cranio-maxillofacial area. The company employs around 1,400 people at 13 locations and sells its products in over 50 countries worldwide.

For more information, please visit our homepage www.medartis.com.

We look forward to receiving your complete online application.

We look forward to receiving your complete online application.

Medartis

Human Resources

jobs@medartis.com

www.medartis.com

Human Resources

jobs@medartis.com

www.medartis.com