Senior QA Specialist
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Søborg
Senior QA Specialist - Product Development
Do you want to be a part of a strong QA department and be the QA representative in one of our strategically important product development projects - in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.
Every 3rd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!
Quality Assurance specialist in exciting product development projects, and cross-functional collaboration
Quality Assurance is one department with 14 skilled and dedicated colleagues counting 10 QA Senior Specialists/Specialists, a Lead Auditor and 3 Technicians. Together, we contribute all the way from product development to first receipt of raw materials to the finished products is released to the market. We are involved in daily operation as well as providing support for various product development projects ensuring compliance both internally as well as with our external partner and subcontractors.
Our environment is very welcoming and characterised by team spirit and helpfulness, also in busy times. We believe that people that support each other and have a good time together create the best results.
Your role
In the position as Senior QA Specialist for development projects, you will become QA’s representative in one of our strategically important product development projects and work closely with the project team consisting of specialists from R&D, Clinical Insights, RA and Technology Innovation to develop the next generation of hemostatic products. Your primary tasks cover:
- Design Control - including design planning, design inputs, design output, design reviews, design verification, design validation and design transfer
- Risk management and risk assessment
- Usability
- Sterilization validation
- Qualification and validation documentation - including test methods
- Transport studies and stability studies
You will support the project team as quality expert, set the direction and standards for compliance and quality and have an important role ensuring that Ferrosan Medical Devices continuously develop and deliver world-class products used to stop bleeding during surgery.
About you
You have gathered board QA experience from being QA representative in product development projects from your previous roles. You are looking to join a dynamic company on an exciting journey where you will make difference with your expertise. You like taking responsibility and you are ready to take decisions. Equally important is your pragmatic and collaborative approach taking necessary and fast decisions – we can only succeed as a team across functions and departments. You seek the best solutions without compromising quality and you are used to handling multiple stakeholders and can land a solution with people that do not have your expertise. You are structured, have a good overview and ability to deep dive into detail when necessary
The role requires:
- Work experience from a similar role within the medical device, pharma or medico industry
- A master’s degree within pharmacy, biology, engineering, chemistry or similar
- Experience with ISO 13485 and 21 CFR Part 820 as well as knowledge of the requirements for being in compliance during product development
- Experience with design control and risk management
- Experience with validation and qualification
- Fluency in Danish and English, written and spoken
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 the team?
To apply for this position please contact Peoplement Executive Search Partner Anne Borgen, either by mail: [email protected] or phone +45 61690101 for more information. Application should be submitted latest end June; however, we will be evaluating candidates continuously.
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 4.4.2022, 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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