Job opportunity
Senior Quality Consultant
- Would you like to work for top-tier Danish and international Med-Tech companies?
- Are you experienced within Project Management?
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?
- Do you thrive in a consultant role, in a high pace environment?
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 or keeping existing products on the market.
Job description
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 people, enabling you to continuously build you 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
- Project Management as project manager driving the entire project, or project participant supporting the project
- Organize, prioritize and coordinate work activities with the ability to meet deadlines
- Developing and maintaining QMS, 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
- Continuously develop your skillset to stay up to date
Your background and qualifications
- 5 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, preferably as Project Manager
- Experience with working in a regulated area e.g. MedTech and Pharma
You are
- 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 natural to you
- You listen, consult others and communicate proactively
- You are aware of own strengths and you demonstrate integrity
- You develop and share job knowledge and expertise through continual professional development
- Your judgments are 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 national and international Pharma and MedTech companies across segments and disciplines
- A unique opportunity to become part of a successful and growing company
- Focus on your development and job satisfaction
- An informal and trust-based work culture with professionalism and friendliness as core values, and a welcoming and appreciative approach to employee initiative
- Rich opportunity to make your mark on exciting projects and company culture
- Regular social events to get to know your colleagues
- Attractive salary, health insurance and the opportunity to join the employee stock ownership plan.
Who we are
Technolution is a growing consultancy company, assisting world leading MedTech and Pharmaceutical companies in succeeding with developing innovative medical devices – from idea to launch. We work in compliance with ISO 13485/9001.
Technolution has a flat organization with 55+ employees, covering 9 overall areas of expertise.
We are proud of our collaborative and informal culture where social activities and 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 prototype workshop and test lab.
Being consultants, we are often working at clients’ offices, except on Fridays when we gather at the office for breakfast, socializing and knowledge sharing.
Would you like to apply
Send your application to: job@technolution.dk and type “Senior Quality Consultant” in the subject field.
Do not hesitate to contact Head of Quality, Nancy Fonskov at +45 6172 2100 if you have further questions.
Find more information about Technolution on LinkedIn.
We need your help as soon as possible, so don’t hesitate to apply.
Deadline for application is 15. January 2022, but we conduct interviews continually.
