Uppdrag tillsatt

QA Manager

  • Handicare AB
  • Stockholm
  • Publicerad: 21 augusti, 2019
  • Fulltid

Our commitment is tied to a strong belief that our efforts make a difference in the lives of individuals. We are also driven by the ongoing need to continuously improve, enhance and develop our solutions. We are “Making everyday life easier”!

Our global Quality Team is spread between North America and Europe, and for our Quality department in Sweden, specialized in transfer and bathroom safety products, we are recruiting to further expand our Quality Team.

Reporting to the Head of Operations Patient Handling, the role will give you the opportunity to grow in a truly international company. You will be responsible for ensuring product compliance and maintain and improve the existing Quality Management System.

The role is based at the Handicare office in Kista, Sweden.

Key responsibilities

  • Manage and participate in internal and external audits.
  • Be responsible for and maintain the Quality Management system in both Sweden and the Netherlands and ensure that requirements from the ISO 13485, 9001 and FDA standards are met.
  • Lead the management review and follow-up actions decided by management team.
  • Support the organization in their reviews to identify improvement opportunities.
  • Stay updated on the development of relevant standards and regulations concerning our product areas.
  • Be the company’s contact person for certifying bodies for medical devices.
  • Structure, plan and implement processes, writing routines and creating forms for relevant areas to cover QMS.
  • Perform internal Quality related training.
  • Support Regulatory Affairs function when needed.

Your qualifications

  • Experience from QA in the life science industry – preferably medical devices
  • Knowledge of MDD/MDR and FDA-regulations
  • Project Management skills
  • Excellent English, both written and spoken. Any other language is a merit.
  • University Degree

To be successful you can handle both strategic and operational tasks.  You are action oriented with great planning skills. Working in a cross functional environment you show good informal leadership- and stakeholder management skills.

We look forward to receiving your application.

Please send your CV and cover letter to daniel.kremer@moveup.se

Questions regarding this position: contact Tom Bergqvist CEO Moveup Consulting at  tom.bergqvist@moveup.se +46 (0)733 – 872722

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