Perform a wide variety of activities to support the Quality Management System.
Conduct product testing, including testing to support complaint investigations and stability verification.
Generate product testing results reports.
Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
Conduct spot-checks inspections/audits of production operations.
Participate in the internal audit program.
Write, review and approve Standard Operating Procedures (SOPs) as necessary.
May assist in supporting the Document Control program, record retention areas, and sample retention areas.
May support returned instrument processing.
Log returned instruments from the field.
Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing.
As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Other duties as assigned by supervisor.
Supervisory Responsibilities This job has no supervisory responsibilities.