Quality Engineer

Quality Engineer

Reporting directly to the Quality Assurance and Lab Manager, this position uses critical thinking and technical writing skills to research, develop and document key quality processes such as process and software validations, procedures, risk assessments, PFMEAs, as assigned in a timely manner. This role supports all levels of operations, quality, laboratory, and engineering departments in the development, management and execution of testing and validation protocols. This position will service all aspects of the businesses at PCNA. This role supports the Engineering team with maintaining the facilities' master validation plan. Facilitates the company's Management of Change (MOC) process. Maintain outgoing process data for statistical analyses, trending purposes to ensure the process is maintained as validated. Continuous Improvement Coach and Coordinator. Perform data analyses using ERP, PowerBI, Excel, etc.

POSITION REQUIREMENTS

Education, Credentials, Licenses :

• Bachelor's degree in Engineering (Biomedical, Mechanical, etc), Science (Chemistry, Biology, Physics, etc.), or Math (Statistics) required

Kind & Length of Experience :

IV. PERFORMANCE MEASURES AND STANDARDS

Quality Improvement

ISO Documentation

ISO Management System

Innovation

Peter Cremer Training Required

Customer Service, Teamwork & Code of Conduct

We are an equal opportunity employer. Applicants are considered for positions without regard to sex, race, color, ancestry, religion, national origin, disability, age, marital status, disabled veteran or Vietnam era veteran status, genetic information, sexual orientation, pregnancy, including childbirth or any related condition, gender identity or expression, citizenship, or any other characteristic protected by applicable state, federal or local laws.