• Are you eager to work with Quality Assurance for top-tier Danish and international Med-Tech companies?
• Do you love ensuring high quality in the development of medical devices of the future?
• Do you thrive in a high pace innovative environment?
• Then this is the job for you!
As a Quality Specialist at Technolution you will be a part of a team of experts, assisting our clients in various Quality Management assignments. Your tasks will primarily be client specified projects, working both with supporting device development projects and Quality Management assignments. Internal tasks such as maintaining and improving Technolution’s Management System may occur.
Your colleagues in this job will be among the best in the business and from many different MedTech disciplines. Together you will ensure top-level Quality Assurance as a part of Technolution’s unique integrated service, in a professional, but relaxed and knowledge sharing environment. The job requires extensive knowledge and experience working within a regulated area, and while experience within MedTech and pharma is not a must, it is preferred.
In this job, you will work with many highly skilled persons, enabling you to continuously build you skillset and you will be an integrated part of our clients’ project group for periods of time. Hence, you will naturally build a large network outside Technolution, while at the meantime building strong bonds with all of your colleagues at Technolution through project collaboration, our weekly breakfast sessions and regular social events.
Our approach to Quality Assurance is that regulatory requirements and business aspects need to be carefully weighted to make sure that QMS systems creates real business value in addition to meeting regulatory requirements.
In this job you will:
• Develop and maintain QMS systems, applying your knowledge of ISO 13485
• Implement QMS updates to comply with MDD, MDR, IVD, IVDR
• Review and implement procedures and templates
• Assist in internal and external audits
• Conduct GAP analysis for compliance with relevant directives, regulations and standards
• Handle CAPAs (Corrective Action Preventive Action)
• Give input to setting up Post Market Surveillance systems
• Apply your knowledge of production management and production transfer processes
DESIRED COMPETENCES AND EXPERIENCE
• 4-8 years of experience working in a regulated environment within Quality Assurance and/or Product Development (e.g. Product Verification & Validation, Design Control & Risk Management, SW validation)
• Minimum 3 years of experience with Quality Management Systems for Medical Devices (ISO 13485, ISO 14971, MDD 93/42/EEC, 21CFR820, 21CFR part 4, knowledge of MDR 2017/745)
• Experience with Management System process development (documents, records and templates)
• Experience with Internal Audits and Notified Body audits
• Preferable Certified auditor – 9001 and/or 13485
YOU ARE A PERSON WHO…
• Takes responsibility for actions, projects and people
• Motivates and empowers others
• Listens, consults others and communicates proactively
• Has awareness of own strengths and weaknesses
• Demonstrates integrity
• Develops and shares job knowledge and expertise through continual professional development
• Demonstrates understanding of how one issue may be a part of a much larger system – holistic thinking
• Makes rational judgments from the available information and analysis
• Builds wide and effective networks of contacts inside and outside the organization and at all organizational levels
• Makes presentations and undertakes public speaking with skill and confidence
• A unique chance of being part of a successful growing company
• An informal and trustful work environment where professionalism and friendliness are keywords
• Plenty of possibilities to put your mark on exiting projects and company procedures and culture
• Regular educational sessions on various relevant topics to keep everyone up to date on the latest knowledge
• 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 developing innovative medical devices – from idea to launch. We work in compliance with ISO 13485/9001.
Technolution has a flat organization with 30+ 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 development of our professional skill 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.
See where we are located:
BECOME A PART OF OUR SPECIALIST TEAM
– APPLY NOW!
Join our team of dedicated specialists at Technolution 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.
Don’t hesitate to contact our Quality Manager Marianne Lind if you are interested in this job.