Senior QA Specialist - Qualification/Validation
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Søborg
Senior QA Specialist – Qualification/Validation
We are expanding our QA organisation, and we are looking for a new colleague that is passionate about quality, development and production of Medical Devices. We are a department of dedicated QA Specialists who support our projects and ensure compliance in our documentation.
In Ferrosan 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
You will be part of QA Business Support Team consists of 12 QA Specialists and Senior QA specialists that are allocated to projects including innovation projects, capacity projects and automation projects. You will refer to the Senior Manager for QA Business Support. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.
Your role
As a Senior QA Specialist, you will impact the daily production of our products – the heart of our company. You will:
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.
About you
You have a proven track record from working within QA in life science industry as qualification and validation QA expert. Maybe you are ready to widen your QA role with tasks within design control as supplement to the qualification and validation activities or maybe you already do this. 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:
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. And we take pride in having fun.
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?
Send your application along with your CV at the latest at 31/07 2024. We will process the applications as we receive them.
Questions? Please do not hesitate to contact our Hiring Manager here:
Elisabeth Kjærside Storm Nielsen
Senior Manager, QA Business Support
+45 26 46 21 35
We look forward to hearing from you.
Read more about us here
We are expanding our QA organisation, and we are looking for a new colleague that is passionate about quality, development and production of Medical Devices. We are a department of dedicated QA Specialists who support our projects and ensure compliance in our documentation.
In Ferrosan 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
You will be part of QA Business Support Team consists of 12 QA Specialists and Senior QA specialists that are allocated to projects including innovation projects, capacity projects and automation projects. You will refer to the Senior Manager for QA Business Support. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.
Your role
As a Senior QA Specialist, you will impact the daily production of our products – the heart of our company. You will:
- Participate in qualification and validation projects ensuring that our 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.
- Collaborate with your QA colleagues within the area of qualification and validation e.g. update SOPs for 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.
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.
About you
You have a proven track record from working within QA in life science industry as qualification and validation QA expert. Maybe you are ready to widen your QA role with tasks within design control as supplement to the qualification and validation activities or maybe you already do this. 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.
- Preferably +5 years of QA experience within the Medical Device/Pharma industry.
- Experience within qualification and validation of equipment and processes are knowledge and advantage.
- Statistical skills for qualification and validation.
- Experience with other disciplines within QA area design control, CAPA, change control and non-conformities will be an advantage.
- Fluency in Danish and English, written and verbally.
- Quality, improvement - and a 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. And we take pride in having fun.
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?
Send your application along with your CV at the latest at 31/07 2024. We will process the applications as we receive them.
Questions? Please do not hesitate to contact our Hiring Manager here:
Elisabeth Kjærside Storm Nielsen
Senior Manager, QA Business Support
+45 26 46 21 35
We look forward to hearing from you.
Read more about us here
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 26.6.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Søborg
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