QA Specialist

Are passionate about the quality and production of medical devices?

Job

QA Specialist

If you are passionate about the quality and production of medical devices, you are the person we are looking for. We are expanding our QA organisation again, and we are looking for 2 new great colleagues. We are a team of highly dedicated QA Specialists and technicians who support our Production and ensure compliance in our documentation.

At FeMD, we make a difference in surgical care area, we are ready to invest in you and will support your development and help you grow your own skills. Every 2nd second, Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. Our products make seconds count in surgical care - and we need you on our team to continue our successfully journey.

Our team

In QA Operations Support we are 10 QA Specialists and QA Technicians with broad knowledge about quality requirements for Medical Devices. We participate in all aspects of support to our production and QC e.g., handling non-conformities and CAPAs, qualification and validation of utilities and equipment and product release. Furthermore, we participate in projects both as quality and compliance experts as well as ensuring that our documentation complies with the requirements for Class III Medical Devices.

You will refer to the Senior Manager for QA Operations Support, Anne Mette Wolsing.

Your role

As our new QA Specialist, you will participate in daily support to our production and QC and act as approver of documentation. This will include tasks within the following areas:

Change Control
Complaints
NC’s (non-conformities) and CAPA’s (Corrective and Preventive Actions)
Qualification and validation of QC equipment
Supporting our product release process
Sparring in FeMD regarding quality related matters
Participating in minor operation projects
Training colleagues in QA processes

In this role, you will be in contact with a great part of our organization and your main stakeholders will be our colleagues in our Production and QC.

About you

You have a proven track record from working within QA. You have knowledge about ISO 13485, MDR and preferable the requirements covered by MDSAP. As our 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:

A master’s degree within pharmacy, biology, engineering, chemistry or similar
Some QA experience within the Medical Device industry
Experience with CAPA, Change control and Complaints
Fluency in Danish and English, written and verbally.
Quality, improvement - and want to succeed together mindset.

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. We take pride in having fun and we are looking for you.

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 hemostatic 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?

Apply for the position by submitting your CV including your motivation no later than November 30th, 2024. We will process applications on an ongoing basis, so don’t wait too long. The job ad will be reposted until the position is filled.

If you have any questions, please do not hesitate to contact:

Anne Mette Wolsing

Senior Manager, QA Operations Support

+41 88 95 25

o@ferrosanmd.com">amwo@ferrosanmd.com

Profile

About you

In short, you bring:

A master’s degree within pharmacy, biology, engineering, chemistry or similar
Some QA experience within the Medical Device industry
Experience with CAPA, Change control and Complaints
Fluency in Danish and English, written and verbally.
Quality, improvement - and want to succeed together mindset.

Benefits

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

Company profile

Since 1947 Ferrosan Medical Devices has developed and manufactured haemostatic products, used by clinical professionals to stop bleedings during operations in hospitals. We work in close partnership with Ethicon (Johnson & Johnson), who is responsible for sales and marketing of our products, sold under the SURGIFLO™, SPONGOSTAN™ and SURGIFOAM™ trademarks in more than 100 countries.

We are 350 employees in the headquarter in Soeborg, close to Copenhagen. Our focus is development and manufacturing of products with focus on new, innovative solutions and surgical technique for our customers globally.

Ferrosan Medical Devices operates in two main divisions; Biomaterials & Electromechanics division. The majority of the company operates within Biomaterials that develop and manufacturer adjunctive haemostatatic products.

With a revenue of app. DKK 900m in 2023 we have been experiencing strong growth in more ways than one. First of all, due to the global success of our products, as a rapidly increasing international sales are showing healthy growth. Secondly, with a strong focus on innovation and a sound pipeline of new development projects combined with strong investments in optimizing the existing business. Our company has seen a significant growth in headcount and at the present time.

Read more about Ferrosan:
https://www.ferrosanmedicaldevices.com/who-we-are/