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Design Control Lead
2 weeks ago
Are you passionate about quality, regulatory compliance, and driving process excellence in product development? Do you thrive in a dynamic environment where your expertise makes a real impact? Join us as our new Design Control Lead
About the Role
As Design Control Lead, you'll be responsible for leading and evolving our design control and risk management practices across product development. You'll play a key role in ensuring that our projects comply with internal procedures, regulatory standards, and our quality management system. You'll work closely with cross-functional teams to support documentation, traceability, and continuous improvement.
What You'll Do
- 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
What We Offer
- 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
About You
You are a structured and quality-conscious professional who approaches your daily work with precision and clarity. With a strong ability to grasp complex tasks, you prioritize effectively—even in fast-paced and high-pressure environments—always focusing on what matters most. You're meticulous and detail-oriented, ensuring nothing is left to chance, and you take full ownership of your responsibilities through both successes and challenges. Calm and composed under stress, you maintain stability and drive your work forward with confidence. Collaboration comes naturally to you; you value being part of a team where knowledge, ideas, and solutions are shared openly. Your communication skills are well-developed, and you contribute actively to a culture of continuous improvement and accountability.
Your Experience
- 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
Ready to Join Us?
This is a full-time position based at our
CellaVision HQ in Lund, Sweden
—a modern office with great infrastructure and commuting options. We're looking for someone to start as soon as possible.
Apply Now
Follow the application form and attach your resume. We're excited to hear from you
Diversity is in our blood.
CellaVision is an equal opportunity employer
, and we encourage individuals from all backgrounds to apply. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, nationality, gender, age, sexual orientation, disability, or any other characteristic.
We decline all contact regarding services in advertising, consulting, or recruitment.
About Us
CellaVision is a global leader in digital cell morphology within hematology, and our analyzers are trusted in healthcare services around the world. We focus on innovation, working with the latest in programming, digital imaging, and machine learning to provide value to our customers. By joining us, you'll be part of a creative, skilled team shaping the future of medical technology.
