Quality Systems Specialist presso Teguar Corporation

Description

Teguar Corporation is expanding, and we are currently looking for a Quality Systems Specialist to join our team.

About the Job

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

Your main 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. 

Core Competencies you need…

• 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;

You will be successful in this role if…

• You have a passion to help your organization achieve work class quality standards!
• You have no issues with putting your problem-solving skills to use to take on rewarding challenges.
• You consider yourself to be a valuable asset in helping a company excel in achieving goals of their quality policy.

This role is NOT for you if you…

• Struggle with conflict resolution;
• Fail to communicate barriers that impede your success in meeting deadlines;
• Cannot take constructive criticism intended to support your development;
• Have difficulty being influential in encouraging others to follow policies and procedures at all times;

Who we are…

Teguar Corporation is a fast-growing Inc 500 company who is a leading provider of advanced industrial and medical computer solutions.  Our industrial and medical computers are specially designed to provide reliable performance in the most demanding environments and applications.  

Why Teguar?

We’re a values-driven company that believes in family-first, excellence, integrity, agility, and customer passion. Our team is global, collaborative, and committed to building technology that powers innovation in demanding environments.

Join us and become a key part of shaping the future of industrial and medical computing solutions.

Requirements

• 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.

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