Location
Lexington, MA | United States
Job description
This position employs an individual with quality engineering experience in the medical device industry.
Main functions of this position will require administrative involvement in the creation, implementation and maintenance of Tepha's Quality System, and technical involvement in developing process controls in the manufacturing
environment.
This is a hands-on position requires an excellent understanding of FDA's Quality System Regulation (QSR), and ISO 13485 and EU MDR 2017/745.
Requirements:A minimum of 5 years in medical device Quality with at least 4 years in an Engineering role
Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Capable of using Microsoft programs and ability to learn other systems.
Working knowledge of statistical methods as well as statistical application software.
Effective verbal and written communication skills.
The ability to work in teams and independently with minimal supervision to obtain results as required.
Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
Job tags
Salary
