We encourage and support new ideas and are always seeking to improve the quality of patients' lifes.
Qmedics AG is a privately held, independent Swiss medical technology company founded in 2008. We develop and manufacture stents, stent systems and balloon dilatation catheters. Our portfolio offers standard and customized products, solutions and technologies. With our passion for life, we focus on innovation and enhancement of endovascular implants.
Are you our new experienced professional with passion in validation to support our growing Quality Affairs Team as
The Sr. Validation Engineer Job Description includes writing/executing qualification and validation documents on equipment, instruments, processes, and handle validation deliverables for projects.
Utilizing the lifecycle approach, the successful candidate will ensure activities are performed in accordance with the Site Validation Master Plan, project specific validation plans, and applicable SOP’s.
The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Specific duties include: validation of equipment, Medical device systems and processes.
Develops validation master plans, schedules, master plans, protocols, and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
Coordinates Activities with Validation, Development, Manufacturing, Engineering, Quality, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
- Master’s degree in engineering or relevant technical discipline with seven or more years of experience.
- Five or more years of Research Engineering experience in medical device industry.
- Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities.
- Familiar with statistical software tools (e.g., Matlab) and / or experience in engineering tools and software languages (Visual Basic, SQL, Labview).
- Excellent understanding of design control processes as defined per ISO 13485 / MDD - MDR, including writing protocols, plans and reports to support verification and validation activities for product commercialization.
- Self-starting and self-organizing personality with outstanding problem solving and design skills.
- Excellent command of spoken and written English and German.
You will find a challenging position in a motivated expert team. Qmedics AG is a growing innovative company with the ambition to make a substantial contribution to a world where everyone enjoys life without limitations.
We look forward to receiving your application at HR@qmedics.ch to the attention of our HR Manager Mrs. Monica Baumann. Please note, that we do not work with recruitment agencies to fill this vacancy. Only direct applications will be considered