Quality System Specialist

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 Quality System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP requirements. This role is part of the Global Quality Assurance function and supports the implementation and maintenance of the Site Quality System. This role provides active guidance to multiple departments to ensure adherence to SHL’s Quality and Regulatory procedures, as well as relevant agency policies and regulations. Additionally, the role is directly involved in developing and establishing site-level procedures.

Main Responsibilities

• Build and maintain Site Quality Management System
• Oversees implementation of quality assurance procedures, incl. change control
• 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 3 years’ experience in 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
• Fluent in English both spoken and written.

Preferred Qualifications

• Bachelor’s degree in Life Science or Engineering
• Certification in Purchasing or Supply Chain Management (e.g., CIPS, APICS).
• Certified internal auditor to ISO 13485
• Previous experience in quality management systems for medical device manufacturing organizations
• Certified internal auditor to ISO 13485

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.   

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.