Description
Senior Quality Systems EngineerSUMMARY
The position shall be responsible for management, and control of all exception events. The position shall provide leadership and supervision of the complaint handling, CAPA, Deviation, and investigation systems. The position shall also provide technical, quantitative, and coordination support to assure products and processes are investigated, and are monitored for implementation of corrective actions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review and maintain policies, procedures, and systems for investigations, and corrective action plans related to complaints, deviations, non-conformances, and any other exception event.
- Coordinate investigations of complaints, non-conformances, and negative trends.
- Review and approve/reject investigation reports.
- Supervise and manage deviation system.
- Supervise and coordinate the CAPA system.
- Coordinate the MRB.
- Work with supply chain to maintain the SCAR system.
- Participate in the risk management process.
- Maintain performance versus relevant quality goals.
- Develop and Maintain relevant quality metrics for periodic distribution and review.
- Perform other duties as assigned.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/ or Experience
Bachelor's degree in a technical field required. 5 years experience as a quality engineer in pharmaceuticals or medical devices required. Experience with project management and tracking tools. Familiarity with concepts of electromechanical/biomedical engineering is highly preferred.
Language & Communication Skills
Ability to speak and write succinctly. Ability to effectively communicate information, needs, reasons, justifications and evidence.
Analytical and Reasoning Ability
Open-mindedness, inquisitive, curious, objective, detail oriented. Ability to assess and analyze situations objectively before conclusions are reached. Ability to solve problems with other departments.. Able to hold position and be persistent if factually and data supported
Personal characteristics
Organized, strong work ethic, and sense of responsibility. Able to make things happen and to resolve problems as a team. Able to hold self and others accountable. With the welfare of the company as the only objective, must be able to question and challenge status-quo in a diplomatic and constructive way.
Strategic Leadership
Able to inspire, influence, and enable others to achieve a specific mission. Drives for results, demonstrates initiative without being told. Competence can be seen by how well self and others are developed. Builds winning teams. Works effectively with others to accomplish goals/ resolve problems. Provides clear sense of direction for organization/ department. Secures relevant information. Identifies key issues and sets priorities. Can be flexible when changes occur. Able to anticipate and bring about change when needed.
To find out more about Real Staffing please visit www.realstaffing.com