Quality Systems Engineer, Senior
Introduction:
Our client is a leading biotech company in Cambridge, MA, United States. They are seeking a Quality Systems Engineer, Senior to join their team to manage Change Control, Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management. The Quality Systems Engineer, Senior will ensure compliance with company procedures and industry standards.
Responsibilities:
The Quality Systems Engineer, Senior will be responsible for the oversight of the Quality Systems that allow for efficient and compliant execution of operational projects. The QS Engineer will work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation in compliance with regulations, procedures and policies. The role requires the following responsibilities:
- Oversee the Quality Systems to ensure efficient and compliant execution of operational projects
- Work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes
- Ensure implementation in compliance with regulations, procedures and policies
- Provide guidance to the team on the Quality Systems
- Conduct periodic reviews of the Quality Systems to identify areas of improvement
Skills:
The ideal candidate will have the following skills:
- Experience in Quality Systems
- Knowledge of Change Control, Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management
- Strong communication and interpersonal skills
- Ability to work independently and in a team
- Strong analytical and problem-solving skills
