Senior Quality Specialist Business Support Team, Medical Devices, Ferrosan / 1833
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 3rd 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 Business Support is part of the QA Department, where they are a total of 19 people. QA Business Support Team participates in development or other larger projects both as quality and compliance experts as well as securing that the documentation applies the requirements for class III medical devices. The team consists of 8 QA specialists with knowledge of design control, validation, supplier management and audit. 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.
Senior Quality Specialist
Business 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 development projects together with a dedicated team
You will be part of a team of dedicated QA specialists who support all development projects and secure the products compliance with documentation. You will be part of a company, that makes a difference in surgical care and participate in projects both as a subject matter expert and as an approver of documentation. All the products are medical device class III products, so good QA experience within ISO 13485, MDR and FDA / 21CFR820 is a requirement.
You will have contact with a large part of the organization and your main stakeholders will be in product development department and project organization.
You will be involved in Design Control, Risk Management, Qualification and Validation, Complaint and Adverse Events handling, Change Control and Audit.
Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the development of their products; you will also have every opportunity to develop and grow your own skills. You will report to the Director of Quality.
You have a proven track record from working within QA. Experience from Design Control is especially important. You know your way around IDO 13485, MDR and FDA (21CFR820). 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 and find it easy to communicate complex matters. You have strong analytical skills and apply these persistently to drive achieving the project goals. You are oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance.
In short, you bring:
- Experience as an expert within QA and Design Control
- A master’s degree within Pharmacy, Biology, Engineering, Chemistry or similar
- Experience in working in companies with both development and production
- Experience with ISO 13485 and 21 CFR Part 820 as well as knowledge of the requirements for complying
- Experience with audits, especially MDSAP audits
- 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.
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 “1833/ Senior QA Specialist” by e-mail to email@example.com. You can read more about Best Talent on www.besttalent.dk.