DEKA R&D has an immediate opening for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment.
Requirements
- 4-year engineering degree, preferably in biomedical engineering; OR 2-year engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
- Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Experience with SalesForce is preferred.
- Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals.
- Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
- Good problem-solving and proficient computer skills are required.
- Solid written/verbal communication and organizational skills, as well as attention to detail.
- Sound technical writing skills.
- Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.