JOB SUMMARY

To develop and update processes and forms for Manufacturing and Quality Assurance and to maintain the necessary files and databases for record retrieval.

PRIMARY RESPONSIBILITIES

• Using input from several sources, creates process documents used in QA and manufacturing, assures they are approved, and distributes them for use.
• Updates TCM and Item Data.
• Performs miscellaneous clerical functions to support Engineering, Quality, and Manufacturing.
• Maintains a master list of all documents, which includes their current revision and their location.
• Develops forms and labels as required.
• Maintains a computerized master file for all forms used as part of the quality system.
• Organizes and maintains long-term document storage.
• Maintains training files and works with Supervisors to ensure the training documentation is accurate & complete for all employees.
• Create and update Quality Plans and First Cure Records.
• Create and maintain Certificates of Compliance for product shipments.
• Performs QMS audits as assigned.
• Assist QA with the statistical software (QC-Calc).
• Maintains various QA files (Shelf-life report, Audits, Procedures, Work Instructions, CARs, MRBs, MRRs, RMAs, FAIs, etc.)
• Perform Quality inspections as needed.
• Performs other related duties and responsibilities as required or assigned.

SKILLS AND KNOWLEDGE

• Ability to use Microsoft Word, Excel, and Access.
• General office skills such as typing, filing, etc.
• Familiar with ISO 9001 quality systems.
• Ability to work independently to achieve established goals.
• Reading and computation skills are normally acquired through completing a high school degree.

PHYSICAL DEMANDS

• Normal vision is required.
• Occasional lifting of 20 –30 pounds.
• This is not a remote position.