דרושים קבוצת נישה

The ideal candidate will be self-motivated, driven, and highly organized, with strong communication skills, to drive the development and integration of the instrument Calibration and Quality Control products.

This candidate must have extensive experience in Flow Cytometry, and good Biological Assay development background.

Responsibilities

Develop new Calibration, Compensation and Quality control Assays
Monitor production performance
Reagent Drying process monitoring
Help with Assay production debugging when needed
Participate in meetings with our SJ office, night time, from time to time
Contribute to Assay Development V V efforts when needed
Act as the company Safety Officer
Performing tasks of Bio Laboratory Manager as defined S

Join a leading Medical Device Company as a Director of Quality to be responsible for leading the Quality Management system in compliance with ISO 13485, 21 CFR Part 820, MDSAP and other applicable regulatory requirements. This role oversees quality across the product lifecycle, including design control, operations, and post-market activities.
Key Responsibilities:
Lead implementation and oversight of design control processes for new and modified devices.
Manage and ensure quality in operations: production, final product release, incoming inspection activities, process validation and supplier quality.
Manage configuration and doc control process.
Own and maintain the quality management system, including internal audits, CAPA, complaints, and management review.
Prepare for and lead external audits (e.g. notified bodies, FDA).