Design Control Lead

Role Overview

• 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.