Friday, May 10, 2013

Quality Engineer I

Job Summary:

Performs engineering and/or metrology assignments including instrument calibrations, equipment qualifications and process validations involving laboratory equipment or systems; acts as equipment system subject matter expert for client and regulatory audits; assists laboratory staff in determining and documenting specifications for laboratory equipment; assists with training of Associates in Engineering processes.
Performs instrument calibrations and equipment qualifications for new and existing equipment and other metrology functions as assigned.  Manages metrology assignments performed by outside vendors.

Drafts all pertinent equipment documents as needed including:
Functional Requirement Specifications (FRS)
System Qualification Protocols and Reports
Process Validation Protocols and Reports
Relevant CAPA documents as needed (Nonconformances, Corrective Actions, Preventative Actions, Effectiveness Checks, etc.)
Assists Laboratory Staff to generate User Requirement Specifications (URS) and Equipment Operating Procedures (EOP).

Applies standard engineering techniques to improve various processes.  Works with management, facilities technicians and laboratory technicians to contribute to completion of process improvements.

Interact with current or potential clients and regulatory agencies as required.  Supports client audits with respect to the equipment management system.

Coordinates work with laboratory department Management/Staff and other support groups (i.e.: Quality Assurance, Facilities).

Assist with training of Associates on new and existing equipment and processes.

Perform other duties as assigned by the Engineering Manager.
Recruitment for the following job codes also        


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HR Executive
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