Skills Required:
The individual in the position will be required to facilitate the collaboration of information from medical, R&D,
quality engineering and maintain compliance to the quality system in order to generate a risk management file.
The incumbent will perform other duties assigned as required to support the larger risk management goals and
initiatives.
Responsibilities
1) Act independently with minimal supervision to conduct smaller approved projects. Expected to make sugge-
stion on improvements based on recent technical knowledge.
2) Contribute to the planning and execution of components of the development process, which apply to product
revision or enhancement or a defined piece of a larger project.
3) Ability to manage routine small projects without assistance
4) Investigate and analyze customer complaint data and design documentation. Qualifications The individual
must be proficient in working and generating documents in a GDP environment and a working knowledge of
risk management (ISO 14971) or ability to quickly gain knowledge in this area.
5) Knowledge of the basic principles in various engineering disciplines.
6) Must have initial training in concepts of Six Sigma quality techniques.
7) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
Education / Experience 1) Bachelor of Science in either Engineering or Science
8) Experience with GDPs and GMPs
9)Experience with Design History File (DHF), strongly preferred.
10)Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint Nice to
have Software: Trackwise 8, Minitab & DOORS
11)Previous compliant experience, nice to have
Education : Bachelors in Mechanical Engineering is required
