Senior QA

Nucleix Ltd. develops, manufactures, and brings innovative non-invasive cancer molecular diagnostics tests to market. The company’s EpiCheck® core technology combines robust and highly-sensitive biochemistries with sophisticated algorithms to detect subtle cancer-specific changes in DNA methylation patterns and deliver excellent clinical performance. Bladder EpiCheck® is the company’s first on-market urine test for monitoring bladder cancer recurrence and is followed by an active pipeline focused on developing best-in-class yet affordable blood tests for early detection of lung cancer.

We encourage you to express your interest in this opportunity by sending your responses directly to us. Please send your application or reactions to: [email protected]. We look forward to hearing from you! 

JOB SUMMARY:

The Senior QA will be involved in the oversight and support of the manufacturing of high-quality medical diagnostics products, helping with the management of production and QC processes at Nucleix. He/she will ensure efficient production cycles and drive independent projects related to manufacturing with the operational team. In addition, he/she will manage all QA-related activities from incoming inspection of materials, process improvements, investigations, the batch release and shipment of products to customer.

Key Responsibilities

1.    Support the transition from the IVD Directive (IVD-D) to the new EU IVD regulations (IVD-R)

2.    Provide quality guidance and ensure all QA and regulatory requirements are met throughout the company.

3.    Train employees on quality related processes.

4.    Manage manufacturing activities in-house and outsourced.

5.    Create work instructions related to the QMS.

6.    Manage quality processes such as nonconformities, CAPA and ECO related to production.

7.    Support internal and external audits.

Qualifications

·      Academic degree in the field of Engineering, Life Sciences, Quality or a related discipline (paramedical) degree (e.g. pharmacology, medical science)

·      At least 4-6 years of QA experience in the field of Diagnostic (IVD) or Medical Device (MD)- mandatory

·      Prior experience in manufacturing QA - mandatory

·      Knowledge and understanding of Medical Device Regulations (e.g. ISO 13485, IVDR) - mandatory

·      Production oriented approach to quality – mandatory

·      Prior experience in leading nonconformities, CAPA and ECO processes – mandatory

·      Excellent written and verbal communication skills in English

·      Ability to multitask and work under pressure

·      Strong attention to details, integrity and ethics

·      Ability to work independently and as a team

·      Prior experience in Software QA – advantage

·      Experience in supporting CE / ISO 13485 / FDA-QSR / CFDA Audits - advantage

·      Knowledge in design control processes – advantage

The ideal candidate is a mature and professional team player with a “roll-up your sleeves” attitude, team leader, strong communication skills, ability to prioritize tasks, manage tasks, work independently and work under pressure.