About the company
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
As part of the quality engineering team at SHL you will work in close collaboration with your risk management and quality colleagues, as well as several other functions in the organization.
The Quality Engineer in the role as Risk Manager plays an important part in leading and supporting risk management activities, crucial for the product design and development work. The Design FMEA for the products is generated by the Mechanical Designers in close collaboration with the Risk Manager. Also, the Risk Manager is responsible for critical review of the design from a risk perspective and supports the Mechanical Designers in identifying appropriate risk mitigations, as well as reviewing different verification activities to ensure that the risk mitigations are implemented and work as intended. It is therefore of great importance that the Risk Manager possesses solid technical engineering skills, and a creative mind.
The intent is to evolve with time in this role, and work with quality engineering in development projects and other quality element activities, such as Quality Management System improvements and fulfilments.
Main Responsibilities
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To support the project team to conduct the risk management activities, to establish a risk management file.
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To participate in design reviews as Risk Manager.
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To be responsible for customer communication related to risk management activities in the customer design and development project.
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To participate in the implementation and administration of SHL’s risk management process in the Sweden office.
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To participate in CAPAs and change controls as Risk Manager.
Skills and Qualifications
Minimum Requirements:
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3-5+ years of relevant work experience.
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Experience working with regulations and ISO standards, specifically EN ISO 14971:2019 and EN ISO 13485:2016.
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Experience working with Risk Management, Quality Assurance, and/or Regulatory Affairs.
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Engineering degree, such as Mechanical Engineering or Medical Engineering.
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Fluency in English, speech and writing.
Preferred Requirements:
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Experience from working with risk assessments for medical devices.
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Experience from working in a global, matrix organisation.
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Experience from working with pharmaceutical companies.
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Experience from establishing, reviewing and approving quality documentation.
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A collaborative and communicative mindset.