TEGUAR · 1 day ago
Quality Systems Specialist
Charlotte, NC
Full-time
Onsite
Entry, Mid Level
2+ years expTeguar Corporation is a fast-growing Inc 500 company providing advanced industrial and medical computer solutions. They are seeking a Quality Systems Specialist responsible for supporting the Quality Management System, conducting audits, and ensuring compliance with various regulations.
ComputerHardwareInformation TechnologyManufacturingMobile DevicesSoftware
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
Qualification
Required
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
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
Preferred
Experience managing measuring & tool equipment (MT&E) & gage calibration systems, preferred
Experience using QMS software to generate nonconforming reports/records preferred
Benefits
401K matching
HRA (Health Reimbursement Account) covers medical, dental and vision expenses
Gym membership
Basic Life & AD&D Insurance
Optional Supplemental benefits available
Paid Holidays and PTO days
Birthday PTO and Volunteer Day
Culture Committee Program
Employee Referral Bonus Program
Modern office work environment with free drinks and snacks
Company
TEGUAR
Teguar is a leading manufacturer of cutting-edge computer solutions for the medical and industrial industries.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jonathan Staub
CEO & Owner
Recent News
2026-01-05
2023-12-24
2023-12-24
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