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Senior Quality & Regulatory Affairs Engineer

 

Description

Phillips-Medisize is a leading expert in design, development and production of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide.

We are growing and need an additional manager for the Quality Assurance & Supplier Quality Engineering team. You will be the manager for 12 dedicated and highly skilled employees. The team is new and made from members of two sister teams, which you will work closely together with. The employees from the team is placed both in Struer and Virum and you need to make regular travels to be present. You will be part of the quality department and reporting to the Director of Quality Assurance & Regulatory Affairs.

What You Will Do In Your Role

Key responsibilities include:

  • Lead a team of highly skilled Quality Engineers
  • Coaching and development of employees
  • Keep overview of the team activities and allocate resources to projects and tasks based on the company priorities.
  • Drive team performance to ensure obligations are met
  • Be in continuous dialogue with internal and external stakeholders
  • Drive alignment across team and improve the processes
  • Support decision making to ensure compliance and progress
  • Ensure audits and inspections are passed in the development and supplier areas

    The Experience You Will Bring

    Requirements:

    • For this position, the minimum required qualifications are:
    • A Master or Bachelors degree in engineering
    • Proven experience in leading, motivating and supporting highly skilled staff in professional and personal development
    • Solid experience from the medical device industry working within Quality - ideally you have worked with multi discipline medical device development and supplier quality assurance.
    • Personal qualifications

    You take active lead in complex discussions with hands-on execution. From previous experience you know how to ensure the required level of quality in a fast-paced environment. At the same time, you are open for input from colleagues and have a team-oriented mentality. You have a holistic mindset and the ability to keep focus on the critical details. In your new role you:

    • Understand, handle and utilize the diversity of people
    • Understand the value of and exercise value-based management
    • Persistent with a systematic approach to your work
    • Have drive and can plan, execute and implement changes in an organization

      What we Offer:

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