Quality Engineer with focus on Risk Manager
Stockholm, Sweden
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
The Risk Manger is responsible for reviewing risk management related topics within Design and Development Projects and participates in the development, implementation and administration of SHL’s risk management processes. The Risk Manager will carry out activities in accordance with SHL’s QMS, following Quality Policy, Standard Operating Procedures and Work Instructions that apply to the position.
Main Responsibilities
To support the project team to conduct the risk management activities, to establish a risk management file.
To establish documents and approve established documents and records as Risk Manager.
To participate in design reviews as Risk Manager.
To be responsible for customer communication related to risk management activities in the customer design and development project.
To participate in the implementation and administration of SHL’s risk management process in the Sweden office.
To participate in CAPAs and change controls as Risk Manager.
Skills and Qualifications
Minimum Requirements:
3-5+ years of relevant work experience.
Experience working with regulations and ISO standards, specifically EN ISO 14971:2019 and EN ISO 13485:2016.
Experience working with Risk Management, Quality Assurance, and/or Regulatory Affairs.
Engineering degree, such as mechanical engineering.
Fluency in English, speech and writing.
Preferred Requirements:
Experience from working with risk assessments for medical devices.
Experience from working in a global, matrix organisation.
Experience from working with pharmaceutical companies.
Experience from establishing, reviewing and approving quality documentation.
A collaborative and communicative mindset.
Fluency in Swedish.
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.
