Senior QA Specialist – Validation & IT/OT, Ferrosan Medical Devices, 1863 / 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
You will be part of QA Business Support Team consists of 10 QA Specialists and Senior QA specialists that are allocated to projects including innovation projects, capacity projects, and IT/OT projects. You will refer to the Senior Manager for QA Business Support. They participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.

                                             Senior QA Specialist – Validation & IT/OT

• Truly purpose driven workplace, where you can have real impact                         
• Help surgeons to control bleedings and complications during surgical procedures
• Work with Business support together with a dedicated team

The Challenge
Ferrosan Medical Devices is expanding their QA organisation, and they are looking for a new colleague that is passionate about Quality and production of Medical Devices. They are a department of dedicated QA Specialists who support their projects and ensure compliance in their documentation.

Your role
As a Senior QA Specialist, you will impact the daily production of their products – the heart of their company.

You will

• Participate in qualification and validation projects ensuring that their validation activities are completed on time and in the right quality as a subject matter expert and as an approver of documentation
• Review and approve change controls, non-conformities, CAPAs, complaints and SOPs
• Participate in qualification and validation projects for IT/OT
• Be a good and constructive sparring partner for the organisation regarding quality related matters, train colleagues in QA processes, maintain QA processes and drive a Quality Mindset

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

Your Talent
You have a proven track record of working within QA. You have knowledge about ISO 13485, MDR, and preferable the requirements covered by MDSAP. As their products are based on raw materials 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 a high level of quality and compliance.

We expect you to have:

• A Master’s degree within Pharmacy, Biology, Engineering, Chemistry, or similar
• More than 5 years of QA experience within the Medical Device industry
• Experience within qualification and validation of equipment and processes and/or software as IT/OT, GAMP5 knowledge is an advantage
• Statistical skills for qualification and validation
• Experience with other disciplines within QA area CAPA, Change Control, and complaints will be an advantage
• Fluency in Danish and English, written and verbal
• Quality, improvement - and want to succeed together mindset

Ferrosan Medical Devices offers a truly purpose driven workplace where you can have real impact
They offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to their new colleagues. They are driven by improving patient outcomes and they take their values to work every day – they care about each other, their environment and their customers and they win for patients with innovative high-quality solutions.

They 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 they take pride in having fun.

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 “1863/ Senior QA Specialist IT/OT” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.