Quality Systems Specialist

Teguar Corporation•Charlotte, NC

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About The Position

This position is primarily responsible for providing support for Teguar's Quality Management System.

Requirements

Problem solving and reasoning skills
Team player with interpersonal skills
Motivated self-starter that takes initiatives
Proficiency with monitoring and measurement tools (I.e., calipers, tape measurer, etc.)
Technical writing (i.e., procedures, work instructions, etc.)
Data gathering, analysis and reporting
Bachelor's Degree from a four-year college or University and a minimum of 2 Years of experience in Quality role; Or a minimum of 5 years' experience in lieu of a Bachelor's Degree; Or an equivalent combination of education and experience.
Working knowledge of ISO 9001:2015 / 13485 / AS9001 or TS16949 QMS.
Experience conducting both internal and external audits and have an in-depth understanding of technical documentation.

Nice To Haves

Experience managing measuring & tool equipment (MT&E) & gage calibration systems, preferred.
Experience creating & and reviewing technical documents (procedures, inspection reports, etc.).
Collaborating with cross-functional teams in continuous improvement activities.
Document control experience.
Knowledge of lean tools (5S, waster elimination, standard work).
Working knowledge of root cause analysis and CAPA methodologies (i.e. 5WHY, Ishikawa cause & effect analysis, DMAIC, 8D).
Data collecting and analysis.
Experience with manufacturing ERP systems (NetSuite is a plus).
Experience using QMS software to generate nonconforming reports/records preferred.

Responsibilities

Maintains records in a Quality Management System (QMS), including change controls, corrective and preventative actions, and documentation control.
Supports internal audits based on ISO 9001:2015 or other QMS / audit standard requirements. Manages the external audit process with vendors.
Supports continuous improvement for QMS processes in compliance with various regulations (ISO 9001, FDA, GMP).
Extracts, analyzes, and summarizes product information for submission to regulatory agencies or to fulfill other internal or external requests.
Researches regulation changes and provides applicable training programs for the organization.
Works collaboratively with all employees to define processes that deliver our business services with maximum efficiency.
Performs periodic review of external providers and works with external providers and management to improve the external provider's performance where needed.
Reviews process flows, and other information to understand methods that are applied and activities that take place in services.
Works closely with cross-functional teams, including product design, product management, and production, to identify and mitigate quality risks.
Designs control systems in order to ensure that products meet quality standards.
Creates and implements inspection criteria and procedures.
Decides whether to accept a product or continue business with a vendor based on a review.
Reviews data obtained during all quality control and quality assurance activities to ensure consistency with company policies and procedures.