Job Description

Summary:

The Quality Assurance Tech is responsible for ensuring timely and effective implementation of all company's policies, procedures, and activities involved in assuring the quality of manufactured products. Maintains close working relationships with the Quality Engineer, QC Inspectors, and supervisory personnel to meet and maintain product quality, identify, solve, and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements. The QA Tech is responsible for auditing and maintaining ISO compliant processes and standards for business process, production, development, and general operations.
This position reports directly to the Quality Manager. This is an hourly position in which overtime may be required as determined and approved by the Quality Manager. In addition to the listed responsibilities, there may be other responsibilities when required.

Essential Duties and Responsibilities:

Program Development
Assist in development of Control Plans, Process Flows, PFMEAs, and other required PPAP or FAI documentation Assist in PPAP process and maintain documentation for PPAP, TFAT, IQ/OQ/PQ, and other production qualification requirements Maintain compliance with SOP, current Good Manufacturing Procedure (cGMP) and regulatory guidelines

Quality Assurance
Perform Quality Acceptance tests of product and Quality Assurance process audits Update QC procedures as needed Provide guidance to inspectors, operators, processors, and supervisors regarding customer agreed specifications Train inspection personnel on inspection methods and criteria for products Assist with QC inspection activities on the production floor Ensure that products meet customer needs and expectations Maintain 5S standards in the Quality Lab Perform QA reviews of training records and deviation reports. Initiate MRB records in IQMS, review associated documentation, and facilitate the movement of products through the MRB process


Quality Management System
Assist with the sustainment and full utilization of the Quality Management System Problem solving and troubleshooting of quality issues with operations and technical department, and facilitating the CAPA (Corrective Action and Preventative Action) Implement corrective action plans and monitor the effectiveness of the solutions Support internal audits and the internal audit schedule Keep calibration equipment up to date, prepare/send equipment out for calibration, approve calibration records

Document Control
Control of customer drawings and other technical specifications in IQMS Facilitation of yearly review of Standard Procedures with Process Owners Quality records maintenance and document control according to ISO 9001 Reviews customer drawings, Operator/QC procedures and keep revisions up-dated Maintains equipment calibration records

Leadership
Be a liaison between manufacturing and quality control Participate on teams that require technical expertise Maintain a high level of professionalism Promote and participate actively in continuous improvement Maintain working relationships with other department personnel Perform other tasks as directed by manager Must be willing to work overtime as needed

Supervisory Responsibilities:

Acts as Quality Engineer's proxy in the absence of the QE.

Qualifications:

Ability to interpret part prints, quality plans, work instructions, and apply the knowledge appropriately Ability to develop and write technical documents and train personnel Proficient in use of Office software including word processing, database, and spreadsheets Ability to generate, read and interpret statistical reports Must possess excellent written, verbal, and interpersonal communications skills to interact within all levels of the organization Demonstrated experience in formalized problem solving, 8D's, 5 Why's, Fishbone. Comprehensive knowledge of ISO 9001: 2015 Ability to use testing equipment i.e., calipers, micrometers, dial indicators, optical comparator, CMM for part measurement Must be able to work with minimum supervision

Education and/or Experience:

High School diploma or equivalent required Must have at least 4 years experience in any combination with Quality assurance/improvement/control 1 year of Mechanical/Industrial experience preferred Lean/Six Sigma training preferred

Mathematical Skills:

Mathematical knowledge, including algebra and utilization of sampling and statistical charts Ability to perform complex applications of percentages and averages and ratios

Reasoning Ability:

Ability to deal with ambiguous situations, make decisions and take charge of production situations with clear and calm demeanor

Certificates, Licenses, Registrations:

ASQ Quality Designations preferred Six Sigma Green Belt or Black Belt training/ certification preferred

Physical Demands:

Extended hours sitting and viewing a computer screen, repetitive hand and wrist movements. Standing, sitting, walking, bending, stooping, crouching, kneeling, lifting up to 50 pounds occasionally

Work Environment:

* Manufacturing environment with associated noises, smells and temperatures