QA & Doc control specialist

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.

As the QA & Doc Control Specialist, you will be responsible for all aspects of document control according to established procedures. In addition, you will assist the QA Manager at Syqe in controlling and managing the quality management system via internal auditing, CAPA and complaints handling, preparation of periodical data analysis, management reviews, control of non-conformance, and control of changes.

Responsibilities:

Quality Assurance

• Support and active involvement in improving the company’s QMS and internal quality process.
• Open and handle CAPA, including identifying the cause, root cause, correction, and corrective actions.
• Responsible for the company’s employee Training on QA aspects.
• Cooperating in the setting of quality objectives in the company processes.
• Ensure the company’s quality system procedures and products comply with regulatory guidelines and external standards.
• Performing Data Analysis.
• Support production processes and R&D via ECOs, Risk Management activities, internal auditing, and more.
• Initiate, as applicable, Nonconformance Reports. Participate and prepare materials for Management Reviews.
• Participate in external regulatory audits conducted by the Notified Body.
  
  

• Lead efforts to improve the migration of documentation from a manual system to an electronic system
• Maintain all controlled Quality System documents according to established procedure.
• Manage the flow of documentation within the organization
• Support and assist all functional departments with regard to documentation control functions.
• Be knowledgeable of and follow the applicable provisions of the QA department’s standard operating procedures (SOPs) and good documentation practices, as well as remain knowledgeable on an ongoing and timely basis as changes in the SOPs occur.
  
  

• 2+ years of hands-on experience in a Quality Assurance department in the Medical Device industry.
• 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 - An advantage.
• Experience with quality management systems interactions and external NB audits - An advantage.
• A Bachelor’s degree in a technical or scientific discipline is an advantage.