Develop and maintain procedures for design control and risk management.
Ensure compliance with internal processes and external regulations.
Support development teams with documentation and requirements management.
Maintain traceability between design inputs and outputs.
Participate in internal and external audits.
Contribute to evolving our ways of working toward more agile practice.
Requirements
Master of Science in Engineering or equivalent, medical technology, quality, or related field.
Several years of experience working with quality systems and regulatory requirements in product development.
Deep knowledge of QMS and strong understanding of QSR (21 CFR Part 820), ISO 13485, ISO 14971, and ISO 62304.
Extensive experience of both reading and creating quality-controlling documents.
You are used to summarizing your work in reports and express yourself clearly in spoken and written English.
Corresponding skills in Swedish is meritorious.
Bonus: Familiarity with agile development methodologies.
Benefits
Inclusive, Innovative Culture: Work in an international, collaborative environment focused on executing big ideas and adding customer value.
Work-Life Balance: Flexible hours and reduced working hours to help maintain balance.
Job Security: We offer a collective agreement, including comprehensive insurance, occupational pension, parental leave supplements, and more.
Health & Wellbeing: We support your health with free access to a gym, wellness allowance, lunch benefits, sponsored running competitions, and discounts on gym memberships.
Modern Workplace: Enjoy a vibrant, collaborative office environment that encourages teamwork and innovation.
Team Spirit: Join us for weekly breakfasts and fun team-building activities.