Quality Engineer 2
Responsibilities:
- 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 that requires an excellent understanding of FDA's Quality System Regulation (QSR), and ISO 13485 and EU MDR 2017/745.
Requirement:
- 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.).