QA Lead for Medical Device or Combination Products Development - Conseil Stratégie Médicale (CSDmed)Postuler
Do you like challenges?
Do you seek for reaching ambitious goals?
Do you love managing complex, high-tech product development projects in an international and multi-cultural setting?
Do you naturally motivate teams you are part of to achieve inspiring goals through teamwork and dedication?
Then you may be the QA Lead we are looking for.
Draw your own challenges
CSDmed is a fast growing company in the area of consulting for medical devices and combination products located in the Principality of Monaco. Join us on our exciting journey and help us develop innovative solutions to improve the life of thousands of patients across the world.
You will be part of CSDmed. You will settle on the French Riviera, you will have a contract in Monaco, and follow Monaco healthcare and pension plans. You will work for and with clients all across the globe. Remote office is appreciated.
Your Key Responsibilities may include
- Define compliance requirements for project teams and participate in identifying specific deliverables for clinical trials and commercial product.
- Ensure Quality Management System compliance by providing input and/or updates to procedures as appropriate.
- Participate in or lead Root Cause Investigations.
- Ensure development, risk management, human factors activities, tasks and deliverables are complete by conducting Design Control document reviews and Phase audits.
- Review and final approval of product development specifications
- Pro-active stakeholder management - both to internal and to external partners or subcontractors
- Leading skilled cross functional project team (Product Management, Quality Assurance, Regulatory Affairs, Operations, R&D, Clinical Affairs)
- Leadership and motivation of the people working in the project
Your Experience Range allows you to provide support in fields like
- Technical files construction
- Design Controls
- Risk management activities
- Biological evaluation and biological risk assessment,
- Sterilization validation,
- Aging verification, stability testing
- Shipping qualification,
- Design Verification activities
- Operational Qualification
- Human Factors Study
You may be familiar with various standards or regulations like
- ISO 13485 and 21CFR820
- 21CFR210 and 21CFR211 would be a plus
- MDR 2017/745
- ISO 14971
- IEC 62366 and AAMI HE75
- ISO 10993
- ASTM D4169 and ISTA 3A
- ASTM F1980
- ISO 11607
- ISO 14155
CSDmed offers the opportunity to lead various types of projects: concept projects, new product development, and product sustaining.
A proven track record in technical product development
In order for you to be a success in this position, it is essential for you to have a documented experience from companies within the area of medical devices or combination products. Furthermore, we expect you to hold a relevant degree in combination with at least 3 years of experience from the above-mentioned areas.
Required Skills And Qualifications
- Master Degree in Industrial Microbiology and Biotechnologies, or in Biomedical Engineering
- A minimum of 3 years of experience in medical device industry
- Experience from working with cross-professional teams across multiple sites
- Fluency in English (spoken/written); mastering French will be an advantage
- Experience from medical device / combination products development and medical device standards will be an advantage.
Team player by heart
- You are results driven, and know how to set goals – and how to reach them with your team
- You think and act holistic and like to take responsibility
- You are a skilled in creating and maintaining good relations to all parts of the organization
- You have a natural authority in you management style
- You have a general technical insight and curiosity to support a multi-disciplinary work environment
- You are a team player by heart with a natural ability to motivate
- You are pragmatic and strive for efficiency in all that you do
- You are able to travel to meet and work with the customers
Why you should apply
We can offer you an informal and open working environment that does not lock you into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference.
At CSDmed, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.