Vacancy expired!
- Own creation and updates of Risk Management Files.
- Participate in teams in supporting quality disciplines, decisions, and practices for risk management.
- Resolves project issues by working with team members, project customers, and others as appropriate.
- Interfaces with management and cross functional teams on significant matters, often requiring the coordination of activity across organizational units.
- Mentor, coach, and train new product development teams and sustaining engineering teams to create or maintain product risk assessments
- Bachelor's degree
- Engineering experience and demonstrated use of Quality tools/methodologies.
- Knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid communication and interpersonal skills.
- Strong project management skills, including the demonstrated ability to lead multi-departmental project assignments and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred.
- Experience with risk management (ISO 14971) is preferred. Knowledge of various tools and techniques for Risk Management is desirable.
- Knowledge of devices used for PTCA and PTA is desirable.
- Knowledge of various tools and techniques for Risk Management is desirable.
Vacancy expired!