Reading Metro Area, Pennsylvania
- Work with Manufacturing, Engineering, and other Quality functions to coordination/review/approval/ GMP documents such as inspection and testing mechanisms, equipment, validation documents and risk assessments, supplier assessments, etc.
- Assists in review or approval of GMP documents from a Quality Engineering point of view.
- Analyzes production limitations and standards.
- Recommends revision of specifications when indicated.
- Formulates or assists in formulating quality document procedures.
- Support gap analysis and closure of gaps identified.
- Support and promote improvement activities for production area(s).
- Uses various statistical and non-statistical problem-solving tools as part of analysis of data, issues, or improvement opportunities.
- Medical Device Experience
- Must have Bachelors of Science Degree in Engineering or Scientific degree (i.e. Chemistry, Biochemistry)