Quality Assurance Sr Technician

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world.

Job Title: Quality Assurance Sr Technician
Location: San Diego, CA



Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite

Job Summary

Duties:

• 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.
• Perform moderate to complex first article, on-line and final dimensional 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 raw materials and component parts using typical inspection equipment and custom equipment including programable inspection machines.
• Complete and maintain all QA paperwork in accordance with established procedures and manufacturing practices including the generation of first article reports, discrepant material reports and QA history log sheets.
• Execute dimensional, visual, functional, and attribute inspections required by approved validation protocols, engineering study plans, special inspection instructions, or other controlled inspection plans.
• Follow written procedures and engineering specifications utilized for inspection and ensure they are kept current and adequate for the inspections performed.
• Provide feedback to QA Management on documents requiring updates or error correction.
• Record raw inspection data contemporaneously and accurately in the approved protocol form, data sheet, or controlled electronic record without interpreting or changing acceptance criteria.
• Compile completed inspection records, instrument outputs, sample identification records, and other required objective evidence to support complete and traceable inspection documentation.
• 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. May be required to complete portions of the Non-conformance Reports including sort/reprocess/rework instructions.
• 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.

Skills:

• Ability to use typical measuring devices (micrometer, caliper, comparator, thread gages, go/nogo gages and custom gages) , test instruments (pull and torque testers).
• Proficiency in using dimensional and functional inspection equipment appropriate to assigned tasks.
• Knowledge and experience with Good Documentation Practices (GDP) and accurate, complete, and traceable raw-data recording.
• Knowledge and experience in sample identification, traceability, segregation, and status control.
• Knowledge of calibration and verification requirements for inspection equipment and the ability to confirm equipment status prior to use.
• Working knowledge of sampling techniques (e.g., ANSI Z1.4.), Good Manufacturing Practices and other regulatory standards required.
• Ability to identify, document, and promptly escalate deviations, unexpected results, equipment issues, and out-of-acceptance conditions.
• Ability to compile complete, accurate, and traceable inspection records and objective evidence with minimal direction.
• Ability to read standard operating procedures engineering drawings; solid understanding of engineering drawings utilizing Geometric Dimension and Tolerancing (GD&T) required.
• Ability to accurately complete technical reports with minimal direction.

Education:

• High school Diploma or GED required.
• Minimum of 3 years applicable experience required.
• Work experience in an ISO and/or regulated industry environment strongly preferred.

TekWissen Group is an equal opportunity employer supporting workforce diversity.