Quality Assurance Technician / Quality Inspector

Job Summary

With direction from the QA Inspection Supervisor(s) and Quality Management perform dimensional inspections on machined and molded components manufactured from internal and external sources per engineering drawings and applicable external standards. Maintains inspection equipment including Vertex and Vectors. Also maintains control of products on hold.

Principal Duties and Responsibilities:

Perform moderate first article , on-line and final dimensional product inspections, working from engineering drawings, procedures, and external standards, using typical inspection equipment such as micrometers, thread gauges, calipers, optical comparator, concentricity gauge, and height & depth gages.

Perform receiving inspections of Finished Goods raw materials and components parts using, typical inspection equipment.

Perform component testing utilizing various inspection equipment such as tensile testers, force gages and custom equipment including programmable inspection machines.

Complete and maintain all QA paperwork in accordance with established procedures and manufacturing practices including the generation of receiving and inspection records, first article reports, discrepant material reports, QA history log sheets, and document change requests (DCR’s) as required. Ensure all handwritten documentation is clear and legible.

Support the qualification/validation of new products/process projects; perform specialized inspections to help engineering develop new products, gages, and inspection methods.

Follow written procedures and engineering specifications utilized for inspection and ensure they documents are kept current and adequate for the inspections performed. Provide feedback to QA Management on documents requiring updates or error correction.

Interact with personnel from departments outside of the Quality Inspection department, i.e. Manufacturing, Materials, Engineering, etc, to improve on overall Quality of product entering into the QA Inspection department, reducing rejections found and reported in QA.

Generate Non-conformance Reports for submitted product found out of specification. Coordinates movement/control/disposition of products that are under investigation for non- conformance. Coordinate shipment of Finished Goods scrap for destruction.
Generate Quality Hold documents and coordinate containment of affected product.

Publish various daily quality related reports.
Perform additional duties as assigned by supervisor.

Using typical MS Office software (Word, Excel, and Outlook) create and perform simple data entry tasks and procedure changes as requested by QA Management.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence (i.e., knowledge, skills and abilities)

· Ability to use typical measuring devices (micrometer, caliper, comparator, thread gages, go/nogo gages and custom gages) and test instruments (pull and torque testers).
· Experience operating or programming programmable inspection machines (vision systems, CMM, etc) in medical device manufacturing and / or clean room is a plus.
· Working knowledge of sampling techniques (e.g., ANSI Z1.4.), Good Manufacturing Practices and other regulatory standards required.
Ability to read standard operating procedures engineering drawings; solid understanding of engineering drawings utilizing Geometric Dimension and Tolerancing (GD&T) required.
· Ability to lift boxes less than 50 lbs
· Attention to detail
· Ability to work independently

Skills:

Good organizational and communication skills Education/Experience Requirements · High school Diploma or GED required. · Minimum of 52 years applicable experience required. · Work experience in an ISO and/or regulated industry environment preferred. Travel Requirements · None F-01694A

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