Quality Systems Specialist (m/f/d)
Trelleborg is a world leader in engineered polymer solutions that protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. And we are where we are because our talents brought us here. In 2023, the Trelleborg Group had annual sales of approximately SEK 34 billion in around 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is listed on Nasdaq Stockholm, Large Cap. \[www.trelleborg.com] (https://eur02\.safelinks.protection.outlook.com/?url\=http://www.trelleborg.com/\&data\=05%7c01%7cmaria.rifaut%40trelleborg.com%7c3b757bb991bb411d827708dba3044535%7c0f86117777224f068db93384e5321a9f%7c0%7c0%7c638283010950261273%7cUnknown%7cTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7c3000%7c%7c%7c\&sdata\=8TeIdPxJaN2pjtmrQi19WoTwOZDKNZxQKFP0DilDVgc%3D\&reserved\=0\)
As a Quality Systems Specialist, you will ensure the effective maintenance and continuous improvement of our Quality Management System (QMS). You play a key role in ensuring compliance with regulatory standards, internal policies, and manufacturing requirements in a highly regulated environment. What you´ll do:
- Support and execute internal, customer, and regulatory audits (incl. ISO and FDA)
- Act as internal auditor and manage audit planning, reporting, and follow\-up actions
- Coordinate and support external audits, inspections, and customer visits
- Maintain and improve audit schedules, documentation, and compliance readiness
- Monitor and analyze quality metrics (e.g. CAPAs, audit findings, deviations) and drive improvements
- Manage and support CAPA processes (investigation, corrective/preventive actions, tracking)
- Ensure proper documentation and lifecycle management of controlled documents
- Support processes related to nonconformities, complaints, deviations, and customer feedback
- Deliver training on quality systems and compliance topics
- Lead or contribute to continuous improvement projects within the QMS
- Ensure all activities comply with GMP, ISO standards, and internal procedures
- Degree in Quality, Regulatory, Business, or related field (min. 2 years) or equivalent qualification with relevant experience
- Ideally Bachelor’s degree and/or Auditor certification (ISO 13485 / ISO 9001\)
- Experience with GMP and ISO standards (e.g. ISO 9001, ISO 13485, FDA regulations)
- Ideally 3\+ years of experience in quality/regulatory roles (medical device or similar industry)
- Experience in root cause analysis and problem\-solving (CAPA processes)
- Strong understanding of quality systems and regulatory frameworks
- Analytical mindset with experience in data analysis and trend evaluation
- Structured, detail\-oriented working style with high quality standards
- Fluent in English
- A modern, engaging work environment with opportunities for growth and continuous learning
- International collaboration and a supportive team culture, including flexible and remote work options
- Participation in impactful SAP projects with exposure to diverse and interesting business processes
- Commitment to innovation, excellence, sustainability, and social responsibility — your work contributes to digital transformation and positive environmental and social impact
- Healthy, diverse culinary options in our company restaurant, plus game, relaxation, and fitness zones
- Excellent transport connections (3\-minute walk to S\-Bahn/U\-Bahn) and an on\-site parking garage with 100\+ free e\-charging stations as part of our mobility concept
Start shaping industry from the inside!
Trelleborg is an Equal Opportunity Employer.
We value diversity and appreciate the unique experience and expertise that people from different backgrounds bring to our business. Our ability to innovate and develop groundbreaking technologies is one of our greatest strengths \- and our people make it possible.
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