Manufacturing and Quality Systems Professional

3 days ago


Waterloo, Ontario, Canada KNG Technical Inc. Full time

KNG Technical Inc. is driving innovation in the allergy diagnostic market with a novel point-of-care testing system.

We are seeking an experienced senior process engineer to join our team in Ontario, Canada, where they will lead the transition of R&D assays into an ISO 13485 compliant quality system.

The successful candidate will have a strong background in process development and immunoassay development, with at least 5 years of experience. They should also be proficient in process characterization, capability establishment, and reproducibility frameworks.

Responsibilities:

  • Manage the transition of R&D assays into an ISO 13485 compliant quality system.
  • Coordinate manufacturing activities for commercialization.
  • Collaborate with R&D staff to establish process capability and reproducibility.
  • Develop strategic plans for product manufacturing and expanding operations.

This role presents an excellent opportunity for a motivated professional to leverage their expertise in process development, immunoassay development, and medical device development.



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