2 Senior QA Specialists, Audit Internal & External, Ferrosan Medical Devices/ 1862 / 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 the QA Business Support Team consisting of 10 QA Specialists that are mainly focused on QA support for projects, incl. support to Supply Chain Management. 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.

Within the QA Business support, they are now setting up a team for internal and supplier audits as this is a key area to succeed along with the growth of Ferrosan MD. The team will take on all tasks and projects within the internal audit program as well as suppler quality management activities. The 2 positions will be close partners and will support each other for audits. Overall, this is a great opportunity to build/rebuild the internal audit program and the supplier quality management.

2 Senior QA Specialists, Audit Internal & External

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
Are you passionate about performing audits? And are you excellent at creating great relations with Supply Chain Management? Grab this opportunity to join a rapidly growing company, ready to invest in you. Ferrosan Medical Devices is expanding and are looking for 2 colleagues to cover the areas of internal and supplier audits as well as supplier quality management related tasks.

Your role

As their new Lead Auditor, you will set the direction and lead their internal and CMO/Supplier audit programs in their audit team. You can develop and grow your skills based on your background and experience
Participate in project development activities as the supplier quality specialist
Responsible for developing and maintain SOPs within own area for continuously improvements
Be a good and constructive sparring partner for the organisation regarding quality related matters, train colleagues in QA processes and drive a Quality Mindset
Expect travel activities

In this role, you will be in contact with a great part of their organization and your main stakeholders will be their colleagues in Supply Chain, Product Development and Operations.

Your Talent
As a supplier quality specialist, you will impact the relations to the company’s suppliers when working with Supplier Quality Management and impacting the QMS when the daily work in the organization as intern auditor.

In addition you have:

Experience with auditing either as a supplier Quality Specialist, or Lead Auditor, preferably within a medical device or pharmaceutical company
A Master’s degree in Pharmacy, Biology, Engineering, Chemistry, or similar
Experience in working with supplier management
Proven great stakeholder relationships
Experience with ISO 13485 and 21 CFR Part 820, as well as knowledge of the requirements for complying or willing to learn
Experience with ISO13485, MDR and MDSAP audits
Fluency in Danish and English, written and verbal

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 “1862/ Senior QA Specialist” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.