Syqe Medical
  • Published: September 14, 2021
Category
Job Type
Level of education
Undergraduate
Spoken Language needed
Hebrew, English
Level of Hebrew
Fluent
Location of job
Tel Aviv/ Ramat Gan
How many relevant years experience do you require for the role:
3 years

Description

Syqe is a med-tech company developing technologies that enable the precise delivery of a wide range of therapeutic molecules by inhalation. Utilizing its breakthrough technology, Syqe aims to relieve the suffering of as many patients as possible in the fastest possible way.

Main responsibilities:

- Cooperating in the setting of quality objectives in the company processes
- Ensuring that the company’s quality system procedures and products are in compliance with the regulatory guidelines, regulations, and external standards
- Performing controls and verify quality in production processes and R&D via ECOs, Risk Management activities, internal auditing, and more.
- Ensuring validation processes are performed and documented. Review of applicable V&V protocols and reports.
- As applicable, open and handle CAPA’s, Nonconformance Reports including identification of the cause, root cause, correction, and corrective actions. 
- Participate and prepare materials for Management Reviews.
- Participate in external regulatory audits conducted by the Notified Body.
- Conduct document control activities as needed.
- Conduct training in QA aspects as needed for the company’s employees.

Requirements

Requirements and Skills:

- 3-5 years of hands-on experience at a Quality Assurance department, in the Medical Device industry.
- High familiarization with ISO 13485:2016 requirements and interpretation of the Standard to practical and regulatory-complying processes and procedures.
- Knowledge in Design Control deliverables, change control process, and risk management methods.
- A Bachelor’s degree in a technical or scientific discipline is an advantage.
- Experience with quality management systems interactions and external NB audits
- Experience with R&D QA and with validation & verification  processes
- Familiar with quality management standards and methodologies.
- Fluent English & Hebrew, and writing proficiency.
- Excellent team player with good communication skills in multidisciplinary environments.

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