Quality Engineer

Job Title

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