Staff Quality Engineer Job Description Template
Our company is looking for a Staff Quality Engineer to join our team.
Responsibilities:
- Establish adequate data monitoring and use problem solving techniques to propose and initiate adequate measures for process improvement;
- Represent in internal and external audits;
- Support the maintenance of the Stryker Durham Quality System to meet the requirements of ISO 13485:2016, MDSAP and EU Medical Device Regulation;
- Support new product development and maintenance projects for CMF with quality expertise to make sure that procedures and regulations are met;
- Apply quality processes and standards;
- Provides direction and guidance to less experienced staff;
- Define training concepts and execute trainings for quality processes.
Requirements:
- Significant experience in New Product Development (NPD);
- Bachelors Degree in a science, engineering or related discipline;
- Knowledge of Risk Management, Validation Programs and Design Controls in a highly regulated environment;
- Minimum 5 years work experience in engineering, quality, manufacturing, new product development, or regulatory;
- Experience working in the medical device industry.