Quality Specialist Operation Support Team, Ferrosan Medical Devices / 1853 / CLOSED

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 2nd 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 Team
QA Operation Support is part of the QA organisation, where they are a total of 19 people. The QA organization has recently been divided in 2 teams, headed by the QA Director. QA Operational Support participates in all aspects of support to production e.g., handling of deviation, supplier control and product release. Further they participate in projects both as quality and compliance experts as well as secure that the documentation applies to the requirements for class III medical devices.

The team consists of 8 QA specialists and technicians with a broad knowledge about quality requirements for medical devices. 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.

Quality Specialist
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
• Work with production support together with a dedicated team

The Challenge
Do you want to be part of a company, that makes a difference in surgical care – then grab this opportunity to join Ferrosan Medical Devices. The company is ready to invest in you and will support your development and help you grow your skills. As a QA Specialist you will impact the daily production of their products - the heart of Ferrosan Medical Devices.

As the new QA Specialist, you will participate in daily support to the production, participate in minor operations projects and act as approver of documentation. This will include tasks within e.g.:

• Change Control
• Complaint and Adverse Events handling
• Deviation handling including CAPA
• Validation and qualification
• Product release
• Sparring in FeMD regarding quality related matters
• Training colleagues in QA processes

In this role, you will be in contact with a large part of the organization including colleagues at the Polish site and your main stakeholders will be their colleagues in production. 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 refer to the QA Operation Manager.

Your Talent
You have a proven track record from working within QA of minimum 3 years. You have knowledge about ISO13485, MDR and preferable the requirements covered by MDSAP. As Ferrosan Medical Devices’ products are based on raw material from animal origin and are used at the operating theatre, experience working with class III products is an advantage.

You are a strong communicator with good analytical skills. You thrive in a dynamic workplace, practice go look see / go to gemba, and like to improve and align work processes. You are oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance.

In short, you bring/are:

• More than 3 years’ work experience within QA and medical device industry
• Quality, improvement - and want to succeed together mindset
• A master’s degree within pharmacy, biology, engineering, chemistry or similar
• Fluency in Danish and English, written and verbally.

You are 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.
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 is driven by improving patient outcomes and takes 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 reviews your application on a confidential basis. Forward your application including your CV in Danish or English marked “1853/ QA Specialist” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.