Reading Metro Area, Pennsylvania
Position is open to support a project that is scheduled to end on 06/30/18.
Candidates must be able to work onsite full-time (40 hours) at the Sinking Spring office (no remote work).
First shift schedule (8-5 or 7-4)
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.
Mid-level role (2-3 years experience). Medical Device Experience is a nice to have
Bachelors of Science Degree in Engineering or Scientific degree (i.e. Chemistry, Biochemistry)