Design Control Lead

Do you want to work in innovative development teams? Are you an initiator and good at driving your work forward? Do you have experience within design control in product development and feel ready to take the next step in your career? CellaVision is now looking for Design Control Leads in both hardware and software. Does the position sound exciting? Then you might be the one we are looking for!

CellaVision’s development department is growing and will strengthen our organization in Lund with two Design Control Leads. As a Design Control Lead, your main task is to ensure that the development projects meet regulatory requirements. You will work operationally with multiple development teams and report either to Director Hardware or to Director Software & Applications.



About the position

As a Design Control Lead, you will work operationally with design control and risk management as part of CellaVision's development teams. You will develop strategies within these areas in collaboration with QA. In this position, you will also participate in internal and external audits of applicable parts of our quality system. We run a certified ISO 13485 business where we meet CellaVision's requirement 21 CFR party 820. Our documentation base is administered electronically. CellaVision's products are manufactured by contracted manufacturers in Sweden.

Key tasks as Design Control Lead

- Work with overall routines for product development

- Work with overall routines for risk management as well as and drive this area as part of the development team

- Drive the work with requirements management as a part of the development team

- Collaborate with test leaders to ensure that design output meet design input

What can we offer you?

CellaVision is a world leader in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. This is an excellent opportunity to participate in the whole development process of new products using cutting-edge technologies where quality, development, and innovation are constantly in focus. Other great things with working at CellaVision are:

- We have a friendly and open company culture and a flat organization.
- We have flexible hours to promote work-life balance.
- We have collective agreements, ITP-pension, parental leave supplement, reduction of work hours etc.


Qualifications

- Master of Science in Engineering or equivalent in a relevant field
- Experience of qualified QA work with similar tasks
- You are used to summarizing your work in reports and express yourself clearly in spoken and written English. Corresponding skills in Swedish is meritorious.
- Knowledge and experience of QSR (21CFR 820)
- Knowledge and experience of ISO 13485
- Extensive experience of both reading and creating quality-controlling documents.


Who you are

We believe you have a good structure in your daily work and understand the importance of maintaining high quality work. You have a well-developed ability to understand complex tasks and prioritize between them at a fast pace. You are meticulous, attentive to details and make sure that nothing is left to chance. You take responsibility for your own tasks in both success and hardships and are used to driving your work forward. You act calmly and stable in stressful situations, prioritize and focus on the most important tasks even at times with high workloads. We believe that you appreciate being part of a team where you work together and share information and solutions.

Care to join?

Join CellaVision, put your skills to greater use and help us contribute to lab efficiency and improved patient care worldwide.

Apply to this position by filling in the application form and attach your resume/personal letter. Please prepare to have your documents, such as certificates, credentials and recommendations, ready for a potential interview. We review applications continuously, so please send us yours as soon as possible but no later than January 7, 2022.

This is a full-time position based at the CellaVision HQ in Lund. To know more about the position, please contact recruiting manager Jan Nilsson, Director Hardware, at jan.nilsson@cellavision.com or Per Sennmalm, Director Software & Applications, at per.sennmalm@cellavision (mailto:per.sennmalm@cellavision.).com. We do not accept applications via email.

For questions about the recruitment process, contact Caroline Herrlander, HR Specialist, at caroline.herrlander@cellavision.com

Note that you need a valid working permit in Sweden.

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