- Do you thrive in a consultant role, in a high paced environment?
- Do you have a passion for:
- Facilitating efficient business management systems within the Medical Device industry, specifically IVD and combination products?
- Ensuring patient safety through effective Quality Management processes?
Then join Technolution and become part of an energetic and innovative, rapidly growing company. We can assure you, that you will boost your professional experience and knowledge, while assisting our clients in successfully launching new medical devices.
We expect that you are enthusiastic about Quality Management and eager to learn even more!
As a Senior Quality Consultant at Technolution, you will be a part of a team of experts. Your tasks will be various Quality Management related activities, externally for our clients, and internally in relation to our Quality Management system.
Experience with working within a regulated area is required.
In this job, you will work with many highly skilled persons, enabling you to continuously build your skillset and become an integrated part of our clients’ project group for periods of time.
You will naturally have a large network outside Technolution, and at the same time building strong bonds with your colleagues at Technolution.
Our approach to Quality Assurance is that regulatory requirements and business aspects need to be carefully weighted, to make sure that Quality Management Systems creates real business value in addition to meeting regulatory requirements.
This is what you are going to work with:
- Developing and maintaining QMS systems, applying basic knowledge of ISO13485/ISO9001, extensive knowledge of IVDR and Combination Products
- Reviewing and implementing procedures and templates
- GAP analysis for compliance with relevant directives, regulations, and standards
- Organize, prioritize and coordinate work activities with the ability to meet deadlines
- Continuously develop your skillset to stay up to date
About your qualifications
- 5-10 years of experience working with IVD and Combination Products
- Quality Management Systems ISO13485, ISO9001, MDR/IVDR and other regulations (e.g. FDA regulations for MD, IVD and Combination Products)
- Experience with Management System process development (documents, records, and templates)
- Minimum 3-5 years of experience with Project management
- Experience with working in a regulated area e.g MedTech and Pharma
- You are not afraid of taking on a challenge and you do not hesitate to take lead in solving problems
- You take responsibility for actions, projects, people, and deadlines
- Stakeholder management comes naturally to you
- You listen, consult others and communicate proactively
- You are aware of your own strengths and weaknesses
- You demonstrate integrity
- You develop and share job knowledge and expertise through continual professional development
- Your judgments are rational and from the available information and analysis
- You find it satisfying to build wide and effective networks of contacts, inside and outside the organization and at all organizational levels
What you can expect from us
- Extensive contact with elite Danish and foreign MedTech and Pharmaceutical companies, across industry segments and disciplines
- Relevant courses, seminars combined with practical experiences through customer projects
- A unique chance of being part of a successful, fast-growing company where professionalism and unity are keywords
- An informal and trustful work environment where professionalism and friendliness are keywords
- Plenty of possibilities to put your mark on exiting projects and our company culture
- Regular social events to get to know your colleagues even better
- Attractive salary, health care insurance, and possibility to take part in the employee stock program
Technolution A/S is a growing consultancy company, assisting world-leading MedTech and Pharmaceutical companies in succeeding with a license to operate by developing innovative medical devices – from idea to launch. We work in compliance with ISO13485/9001.
Technolution has a flat organization with 45+ employees, spanning over 7 overall areas of competence (Mechanical Engineering, Test & Verification, Quality Management, Usability Engineering, UX & Design, Design Control, and Business Development).
We are proud of our collaborative and informal culture where social activities and the development of our professional skills are paramount.
Technolution is a place where there is room for individuality, initiative, and where everyone is expected to take responsibility. The office in Hørsholm is located in beautiful surroundings and includes great facilities, such as a prototype workshop and a test lab.
Become a part of our Quality team – apply now!
Join our Quality Team of dedicated and highly experienced consultants on our fast and ambitious journey to becoming the leaders of our industry by making all our clients happy through fast-paced, high-quality innovation.
Please send your application and CV to: firstname.lastname@example.org
We are looking at filling this position as soon as possible and will handle applications as we receive them. All applications are saved for 6 months and then deleted.
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