Quality Engineer 2 responsibilities:
- Develop sample plan and data analysis for design verification, new and existing product test methods and incoming inspection
- Ensure products and processes are in compliance with requirements of quality management system and regulatory agencies
- Identify and participate in continual improvement activities to enhance the quality system
- Author, review and approve validations ensuring systems, utilities and processes comply with regulations and standards; participate on validation project teams
- Work with cross-functional teams to solve problems related to product or process issues; investigate non-conformance's, identify root cause, and determine/implement appropriate corrective action plans
- Assist with the development and implementation of statistical process controls
- Assist with quality planning activities to ensure design control and risk management compliance according to regulations
- Update SOPs to maintain the quality management system
- Monitor product quality to ensure product compliance; work to identify and implement improvements
- Participate in internal and external audits
- Prepare engineering reports and CAPAs as needed
- Assist with cross-functional training to build quality awareness
- Complete investigations for confirmed complaints when necessary
Background experience:
- B.S. and 3-5+ years of experience in a regulated medical device or diagnostic environment
- ASQ certification, Six Sigma Green/Black belt, and design of experiments (DOE) a plus
- Proven knowledge of Quality System Regulations
- Experienced in statistical sample analysis and validation
- Knowledge of Microsoft Office
- Knowledge of statistical software, and experienced with ERP system.
Sthree US is acting as an Employment Agency in relation to this vacancy.
