Operation Quality Engineer

FIZE Medical, a fast-growing medical device startup with ground-breaking technology for monitoring critically ill patients is expanding, and we are looking for an Operation Quality Engineer.

As an Operation Quality Engineer you will be responsible for:

• Develop and maintain an effective and robust quality system that complies with all relevant regulatory requirements (ISO 13485/MDR/CFR21/MDSAP).
• Responsible for the management and performance of the QMS, including continuous improvement, quality management reviews, complaints handling, Deviation management, supplier evaluation, investigations, NCs and CAPA.
• Ownership of MRB and CAPA Processes with a focus on:
• Ensuring adequate and timely corrections are initiated, pending completion of evaluations and determination of CAPA requirement.
• Supporting root cause investigation and determination of effective corrective actions.
• Driving comprehensive planning of implementation plans to ensure timely completion.

Job Requirements:

• 3-5 years of experience in a medical device quality assurance role.
• Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
• Good knowledge of QSR regulations, ISO13485 guidelines, MDR and MDSAP policies & procedures.
• Clear verbal and written English communication.
• Ability to organize information effectively, prioritizing tasks according to their urgency and importance.
• Manage stressful situations and controversial issues, firmly adhering to the principles of the regulations and guidelines.
• Proficient use of Microsoft applications – such as Word, Excel, PowerPoint
• Technical/Academic degree – advantage.
• Quality qualification (lead auditor, etc.) and training – advantage.



Sounds Like you? Please send your resume and a cover letter to: hr@fizemedical.com