DET QARA - QMS Specialist

About SHL Medical
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

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 audits 
• Support external audits
• Track KPIs 
• Lead and contribute to CAPA and NCs 
• Contribute to site QARA projects 
• Provide training on quality assurance procedures
• Author procedures, work instructions or other documents.
• Assist QMS Team in daily operations 

Minimum Qualifications

• 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

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.