Quality Assurance Manager
Responsible for managing, directing & implementing all aspects of Criterion Tool & Die, Inc. Quality Department to ensure continuous production of products consistent with ISO 9001 & ISO 13485 standards by performing the following duties personally or through subordinate personnel.
Knowledge of non-destructive testing & measuring techniques
Knowledgeable in gauging methods & their applications
Working knowledge and experience in GD&T, gage calibration, part layout on CMM, optical comparator and surface plate
Must be analytical and able to interpret data
Must have computer skills
Must have problem solving skills
Ability to develop quality control standards, quality objectives and quality control plans
Excellent verbal and written communication skills
Understanding of ISO 9001 & ISO 13485 standards & ability to maintain company quality policy
Essential Duties & Responsibilities including the following. Other duties may be assigned.
Insure that all procedures and processes used in the manufacturing process are in compliance with ISO 9001/2008, 13485 and GMP Standards.
Manage ISO quality System.
Participates on ISO management team & investigates customer complaints regarding quality.
To provide to all concerned, the evidence needed to establish confidence that the quality function is being performed adequately.
Maintain vendor relations pertinent to Quality Assurance & ISO standards: example (surveys, vendor performance, test and inspection of vendor shipments.)
Print Control: review all new prints and verify that the most current revision is on the manufacturing floor.
Process Control: examples (determine capabilities of process, process inspection, investigate causes of out of control conditions, follow-up to secure corrective action).
Inspect and Test: examples (design the inspection and test plan, train inspectors, prepare inspection procedures for each job).
Provides inspection activities for manufacturing throughout production cycle.
Responsible for completion of receiving inspection, in-process inspection, final inspection and inspection documentation as required by the customers.
Directs workers engaged in inspection and testing activities on correct methods to ensure continuous control over materials & and products.
Metrology: examples (construct or buy measuring equipment, maintain calibration, design and administer systems for ensuring maintenance of precision measuring equipment).
Train, monitor & schedule personnel in Quality Department.
Order inspection tooling and gages as needed.
Specific Tasks related to QC:
Review schedule for shipments
Weekly reject form
Weekly meeting w/President on quality issues
Issuing Corrective Actions to in house manufacturing & suppliers
Release jobs to manufacturing
Make up job folder
Review gage's required
Write detailed inspection procedure for jobs
ISO audit schedule: coordinate internal audits
Maintain ISO CA log book
Participate in FDA Audits
Review Schedule- QC responsible for coordination of:
: Jobs completed to be shipped
Jobs at outside services with due dates
Jobs waiting for inspection or outside service
Jobs operator is not able to check
Jobs checked before plate
Review & complete calibration
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|Criterion Tool & Die/Criterion Instrument|
5349 W. 161st Street
Brook Park, OH 44142
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