Quality Management System Specialist

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.

Main Responsibilities:

• 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

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.

We Offer

• An exciting opportunity in a fast-growing international medical device company
• A modern working environment, with multicultural and dynamic teams
• Flexible working hours and a hybrid remote work policy
• A centrally located office in Zug, very close to the train station

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitCH@shl-group.com.

Please note: For this position, we do not consider applications from recruitment agencies.