The DAVIS Companies has partnered with a leader in the medical device industry by securing a Quality Engineer to join their team. This position will be responsible for providing technical quality engineering support for customers, processes and systems, including driving continuous improvement activities.
Quality Engineer Responsibilities:
- Guide CAPA team to root cause and determine appropriate verification of effectiveness strategies.
- Perform QA technical review and approval of documentation for products.
- Report Quality data for management reviews and other Quality reporting (CAPA, NCMR, Compliant, as well as others.).
- Support product and process risk control measures and files (FMECA, pFMEA).
Skills and Experience of Quality Engineer:
- Four-year degree in technical field or equivalent combination of education & experience.
- Training in statistics & experience using Minitab Software preferred.
- 2-4 years' experience in regulated industry (FDA/ISO) preferred.
- Computer proficiency.
- Ability to read, analyze and interpret common technical procedures.
- Knowledge in working with Root Cause Analysis,using quality tools such as Fish Bone Diagramming, Flow Charting, 8D and Value Streaming.
- Knowledge or training pertaining to FDA and ISO regulations