Senior Quality Engineer with focus on Risk Management

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

This role is a key contributor within the Design & Development organization, ensuring that regulatory requirements are met and that products are designed with robustness, manufacturability, quality, and safety in mind. As a Senior Quality Engineer, you will lead critical risk management activities that directly influence product design decisions. You will evaluate design concepts from a risk perspective, guide Mechanical Designers in identifying effective risk mitigations, and review verification activities to confirm that controls are properly implemented and function as intended. Success in this role requires strong engineering expertise, sound analytical judgment, and a creative mindset capable of solving complex technical challenges.

Main Responsibilities

• Lead Quality Engineering activities within design and development projects, ensuring compliance with regulatory requirements, company QMS, and global standards.
• Own the creation, maintenance, and continuous improvement of project risk management files in alignment with ISO 13485 and design control requirements.
• Direct and support all risk-related activities, taking proactive decisions to ensure regulatory and customer expectations are fully met.
• Provide critical review of product design, technical documentation, and design history files to ensure robust quality and safety.
• Participate in and advise on design reviews.
• Collaborate closely with R&D, Regulatory Affairs, and Engineering teams to influence design decisions and ensure strong risk mitigation strategies.
• Act as a senior point of contact for customers regarding quality engineering and risk management topics in their development projects.
• Represent SHL in discussions with global partners, ensuring transparent, professional communication.
• Contribute to the implementation and administration of the risk management process within the Sweden office, aligning with global best practices.
• Participate in CAPAs, deviations, and change controls with a structured, analytical approach.
• Drive continuous improvement initiatives in quality engineering, risk governance, and design control processes.

Minimum requirements

• Minimum 8 years of experience in Quality Assurance within the medical device industry.
• Bachelor’s degree in mechanical engineering, Medical Engineering, or related fields.
• Strong knowledge of GMP and regulatory compliance requirements.
• Experience working with quality processes for medical devices (ISO 13485, design controls, DHF/DMR).
• Demonstrated analytical and problem-solving skills with a structured, methodical mindset.
• Proven ability to operate with integrity, transparency, and high ethical standards.
• Ability to work effectively across cultures and adapt to different market needs.
• Fluent in English, both written and spoken.

Preferred Qualifications 

• Hands-on experience performing or leading risk assessments for medical devices (FMEA, FTA, Hazard Analysis).
• Experience from working in a global, matrix organization.   
• Experience of working with pharmaceutical companies.  
• Experience from establishing, reviewing and approving quality documentation. 
• A collaborative and communicative mindset.  

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.