Quality Assurance Technical Analyst
Chelmsford, MA 01824
Our client is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. Their products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest.
This individual will support procedural requirements of the clients complaint handling and event reporting systems. They will work in conjunction with the engineering team to maintain quality standards across products and platforms. Provide support to investigations that lead to quality improvements. Works with latitude and independence. Reports to Supervisor and/or Quality Assurance Manager.
- Supports Quality Engineers, prepares quality documentation and reports by collecting, analyzing and summarizing information and trends.
- Share time providing support between Manufacturing and Post Market.
- Well versed in developing metrics with initiative towards meeting corporate and department goals.
- Focuses on data
- Initiates data collection
- Coordinates data collection
- Creates reports
- Use statistical methods
- Coordinate QA meetings, meeting minutes, and agendas.
- Communicate with customers and suppliers.
- Perform root cause analysis of product. Including:
- Leading investigation to establish root cause.
- Coordinating failure analysis of non-conforming/defective material with vendors and outside laboratories.
- Propose recommendations for further investigation or improvement driven by data, risk management and root cause analysis.
- Proactively close product complaints and/or document investigation results.
- Other duties as assigned.
- Knowledge of commonly used concepts, practices and procedures related to electronics technology.
- Basic computer skills in a MS Windows environment. Competent with MS Office, including Excel, Access and Word.
- Knowledge of FDA QSR requirements. Knowledge of Medical Device Reporting including international regulations preferred.
- Must be able to communicate verbally and in writing and work effectively within a multi-disciplined organization.
- Requires 2-year degree or equivalent work experience and 6+ years related experience.