Manager of Quality Assurance Operation Support Team, Medical Devices, Ferrosan Medical Devices / 1832

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

Every third second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. They make seconds count in surgical care! And you are needed on their team! See more at https://www.ferrosanmedicaldevices.com/

The Organization and Team
QA Operation Support is part of the QA Department, where they are a total of 19 people. The QA Operation Support Team is a key function in producing and releasing the products to the market with production in Denmark and Poland. The team is responsible for everything from doing batch review and release, deviation and CAPA handling, to participate in projects relating to production. The team consists of 8 people, a dedicated team of 5 specialists and 3 technicians. You can expect a warm welcome! They are helpful and have a team spirit focused on having a good time while creating the best results together.

Manager of Quality Assurance
Operation Support Team, Medical Devices

• Truly purpose driven workplace, where you can have real impact
• Help surgeons to control bleedings and complications during surgical procedures
• Inspire, motivate & lead a dedicated team of 8 in QA Operation Support

The Challenge
Your role will be to lead the QA Operations Support Team. The team will report directly to you, and you will secure that they will delivery on the daily tasks and priorities which are set. You will work closely with your stakeholders in operation. An important task is to set direction on deviation handling and participate in selected deviations. Together with the QA Director you will secure that QA’s overall objectives are met, and the strategic goals are achieved.

All the products are medical device class III products, so good QA experience within ISO 13485, MDR and FDA / 21CFR820 is a requirement.

Ferrosan Medical Devices is an inclusive workplace with the opportunity to have real impact and a development curve. As a leader you can steepen in the pace, that is suitable for your team. You will meet a Danish rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. As a leader you must also take pride in the team achieving the goals and at the same time have fun.

Do you want to lead a team of dedicated QA specialists and technicians 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 of their products; you will also have every opportunity to develop and grow your own skills. You will report to the Director of Quality.

Your Talent
Your most important task is to lead your team in a motivating way. Therefore, good leadership skills are key to having success in the job. You thrive with working among people and getting success together as a team.

You have a relevant education like B.Sc./M.Sc. in Engineering, (Mechanics, Electrical, Chemistry) or a similar relevant background combined with leader experience in a similar function within Medical Devices. Experience with several of the following areas: Compliance with ISO 13485 and 21 CFR Part 820 as well as knowledge of the requirements for complying, controlling procedures in production area, risk management, process validations, supplier evaluations and experience with MDSAP audits, and QA plans.

You are driven by improvement, a strong communicator with excellent business acumen and situational awareness. You thrive being in contact with a large part of the organization. You have strong analytical skills and apply these persistently to drive progress in your teams’ daily tasks. You are oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance. You set directions for the team and secure that deadlines are met.

You are a good communicator, positive, and committed. It is important that you are focused, can prioritize, and keep calm when deadlines are tight. You are good at solving problems and thrive in a busy environment. You are comfortable to lead, facilitate and coach your colleagues when meeting deadlines for quality activities.

You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich Ferrosan Medical Devices’ culture.
You are offered a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to your new colleagues. Ferrosan Medical Devices are driven by improving patient outcomes and take their values to work every day – they care about each other, their environment and their customers and win for patients with innovative high-quality solutions.

Application
Best Talent is responsible for the recruitment process at Ferrosan Medical Devices and review your application on a confidential basis. Forward your application including your CV in Danish or English marked “1832/ Manager of QA” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.