Quality Management System Specialist

at  SHL Medical AG

JOB OVERVIEW

The position of Quality Management System Specialist is responsible for the compliance to all applicable regulations including cGMP. It is part of the global quality assurance function for the Site Quality system. Actively provides guidance to multiple departments regarding compliance to the applicable SHL Site Quality and Regulatory procedures including applicable Agency policies and regulations. Job holder is directly involved in the establishment of Site procedures.

MINIMUM REQUIREMENTS:

• Minimum of 3 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance of medical devices
• Previous experience in quality processes for medical devices
• Experience in GMP and other Regulatory compliance requirements
• Analytical and problem-solving skills
• Operates in a way that never compromises ethics and integrity
• Ability to understand and adapt to different cultures and market needs

PREFERRED QUALIFICATIONS:

• Certified internal auditor to ISO 13485
• Previous experience in quality management systems for medical device manufacturing organizations

EDUCATION AND TRAINING:

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Certified Lead Auditor for ISO 13485 standards.

• Build and maintain Site Quality Management System
• Oversees implementation of quality assurance procedures
• Lead internal and supplier audits
• Support external audits
• Track KPIs
• Lead and contribute to CAPA and NCs
• Contribute to site QARA projects
• Provide training on quality assurance procedures
• Supplier qualification including conducting of supplier audits