Director QA

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Søborg

Director, QA

Do you want to ensure quality as our new Director of QA in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.

Every 3rd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!

Director in QA from A-Z

As Director, QA at Ferrosan Medical Devices you will drive a QA department with a broad scope, leading the quality process from a-z. You will join a successful company with a strong growth in the last few years and record high investments in product innovation and production capacity expansion. You will work in a role that is highly regarded and valued in the company and you will take a seat on the QM&RA leadership team where you can impact the strategic direction of the organization. We are a medium sized company, less influenced by big corporate bureaucracy and with a rather flat organization. Hence, you will have huge impact on further strengthening the compliance platform of the company.

The position reports to the VP of QM&RA and the team consists of 15 highly qualified and well-functioning QA specialists with a strong focus on ensuring compliance across the organization. Our QA department supports all areas of the organization – both daily operational quality work and innovation and optimization projects. We have a vital function in securing safe and compliant products during the development, manufacturing, storage, and shipping of products. This is done by cooperating, supporting, facilitating, training, and communicating with our partners across the company.

As a consultant for the whole organization in all quality matters, QA handles a broad variety of classical QA tasks, such as disposition of products to markets, handling of non-conformities, CAPA’s and changes as well as review and approval of various quality and technical documents. Furthermore, QA is responsible for complaint handling and the investigations and decisions in relation to potential recalls and recalls.

Furthermore, the position will collaborate closely our commercial and innovation partner. In this context, the Director, QA will play an integral role in maintaining the strong and crucial relationship.

Your role

  • Leading, motivating and developing the QA team
  • Setting clear objectives, managing time and resource planning for the QA team, incorporating LEAN in daily task management.
  • Securing a successful performance of the daily operation in the QA team, optimizing, and streamlining the QA area, ensuring continuous improvement to secure a high level of effectiveness and execution power.
  • Ensuring that QA is kept professionally and up to date in relation to applicable rules within relevant GMP/GDP/ISO legislation.
  • Facilitate cross-functional collaboration to ensure accountability and drive for results.
  • Keeping the quality system up-to-date and effectively functioning, including preparing, reviewing and approving controlled documents.
  • Participation in and follow-up on inspections from authorities and customers.
  • Stakeholder management in terms of communication, information to leadership.
  • Ensuring ongoing GMP training for the organization and support that awareness of applicable legal requirements and the requirements of the quality system is spread in the broader organization of FeMD.
  • Approving audit programs and ensuring the planning, execution and follow-up of internal and external audits.

About you

The ideal candidate for the job holds experience from a similar role managing and leading a department of highly skilled QA professionals from a highly regulated industry such as medical devices, pharma, biotech, life science or similar. As a person you have a pragmatic approach – you find solutions to identified problems and you inspire and motivate your team.

  • Minimum B.Sc. – ideally a degree at M.Sc. level.
  • Strong knowledge of quality systems, i.e. ISO, GxP, and FDA.
  • Track record of creating superior project management delivery.
  • Demonstrated track record in finding pragmatic solutions to complex or challenging problems.
  • Highly experienced in stakeholder management.
  • Experience in navigating within larger contexts and organizations preferred and used to environments with changing priorities.
  • Well-versed in setting the direction for a department, and delegation and prioritization of tasks.
  • In your leadership you can build a strong team based on collaboration. You can define a clear vision and have a strategic mind-set looking beyond the immediate difficulties and focus on the far-reaching consequences.
  • You structure and follow up and establish visible and achievable goals for the QA department.
  • Possess strong oral/written communication skills in English.

We offer a truly purpose driven workplace where you can have real impact

We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun 😊

Some of the facts and a little piece of history
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various haemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global MedTech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.

Want to join our team?

Send your application along with your CV to Senior Consultant Henrik Brabrand, Albright Partners: [email protected]. We will process the applications as we receive them.

Questions? Please do not hesitate to contact Senior Consultant, Henrik Brabrand, Albright Partner, either by e-mail: [email protected] or phone: +45 7199 2799

We look forward to hearing from you.

Read more about us here


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 22.8.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Søborg

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