Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
- Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
- May lead or verify effectiveness of corrective and preventive actions (CAPAs).
- Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
- Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
Education & Experience:
- We need someone with technical experience with GD&T and knowledge of blueprint reading and being able to describe the symbols on a blueprint and what the symbols mean.
- Bachelor's Degree in Engineering or related field is preferred
- CAPA, Root Cause Analysis
- Med device and Manufacturing experience is preferred
- 0-3 years' experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T. Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulation