Job Description
SUMMARY
Assists Q.A. Manager by performing the following duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned.
Quality Prevention:
*Creates initial validation protocol.
*Completes validation protocol reports.
*Attends release and layout meetings.
*Directly interfaces with customers to establish quality requirements on new jobs.
*Develops and maintains draft of Quality Plans.
*Oversees FMEA development and completion.
Continuous Improvement:
*Oversees evaluation of internal scrap reports and distributes as required.
*Oversees 6 Sigma program.
*Involved in customer and ISO audits.
*Generates and distributes quality reports.
*Oversees supplier system, including ongoing audits and/or re-assessment.
Quality Appraisal:
*Active in problem solving, investigating and developing corrective actions as needed.
*Has authority to release conforming product.
*Develops batch record plan and maintains ongoing batch release records that go to sterilizer. (Customer specific)
*Reviews and approves sterilization reports.
Statistical:
*Evaluates ongoing statistical/measuring data; implements corrective actions as
needed.
*Creates statistical plans.
*Analyzes statistical data and prepares reports as required.
*Provides customer requested data as required.
Communications:
*Organizes and coordinates Q.A. activities of Quality personnel.
*Directly interfaces with customers to establish quality requirements on new jobs and
resolve customer complaints.
*Performs quality skills training.
Records:
*Maintains Corrective Action Systems including Customer Complaint Files that pertain to assigned Customer.
Supervision:
*Oversees the work of Quality Inspectors as needed.
Supplier Quality:
*Complete Supplier audits.
*Establish Supplier Quality agreements.
*Monitor and update Supplier ISO certification status.
Supervision:
*Oversees the work of Quality Inspectors as needed.
Other:
*Ability to travel as required.
SKILLS:
Bachelor's degree (B.S.) from four-year college or university; or two to four years related experience and/or training with CQI, (CQT preferred); or equivalent combination of education and experience. Will be expected to obtain CQE.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and business correspondence. Ability to communicate with internal and external customers and vendors in a clear and concise manner.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Must be computer literate with spreadsheets, word processing, statistical and calibration software
PHYSICAL DEMANDS While performing the duties of this job, the employee is frequently required to sit and occasionally required to stand and walk. The employee must regularly use hands and fingers to use computer keyboard, handle, or feel objects, tools, or controls. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision.
WORK ENVIRONMENT The noise level in the work environment is usually quiet.