Description
This is a new position that will be responsible for providing leadership for the Quality department on specific product development programs. The Senior Program Manager will act as a key liaison to PreMarket Quality on program, status, conflicts and issues. The Senior Program Manager will support and monitor functional excellence initiatives to improve project performance, oversee Core Team to ensure safety and reliability of the product portfolio.Requirements:
- BS in Engineering or related field
- 8 years experience in engineering or quality related field
- Strong understanding of ISO 13485 and Regulatory standards
- Exceptional communication skills
- Strong mechanical aptitude and methodical problem solving skills
- Strong understanding of Software Development and the SDLC
- Understands concepts of Hardware and Firmware
- Leadership Experience
- Experience in Design History Files or Master Design Documentation
Responsibilities:
- Lead the Quality function for specific projects as a Quality Core Team member for development of medical devices for CRDM product development.
- Develop and review project strategies, with focus on Design for Reliability and QA.
- Resolve any issues with any members of the team.
- Ensure that project goals and project timelines are set and lead effort to meet those goals.
- Ensure project work is done in compliance with the quality system and that ongoing process improvements are adopted as appropriate.
- Review and approve documentation in support of regulatory submissions (DHF's and other quality records).
If you, or anyone you know are interested, please get in contact with me as soon as possible via email, as all first round interviews will be confirmed by the end of this week!
To find out more about Real please visit www.realstaffing.com