Quality Assurance Specialist at Zynex Medical

Posted in General Business 28 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Englewood, Colorado





Job Description:

Full-Time Quality Assurance Specialist

Zynex is seeking the best Quality Assurance Specialist in the state to join our team. Since 1996, Zynex Medical has been a leading provider of relief for patients with functional disability through the creation, distribution and marketing of the highest quality electrotherapy products available today. Our product line is fully developed, FDA-cleared, commercially sold. Zynex continually strives to uphold its mission to improve the quality of life of patients suffering from debilitating pain or illness by providing the highest technology and service standards in the electrotherapy industry.

Essential Job Duties and Reporting Responsibilities Include the Ability to:


  • Reviews and investigates Product Complaints for all Zynex Medical products.

  • Processes and provides data for trending for all Non-conformance Reports

  • Responsible for control, filing, retrieval, and maintenance of master and reference documents, electronic and hard-copy archival system for controlled documents

  • Manage document changes and approvals.

  • Supports the development of QA systems, directives and SOP’s.

  • Initiate, manage, and investigate Corrective and Preventative Actions (CAPA) as appropriate.

  • Maintain records with the device DHF (design history files)

  • Assist in regulatory audits and investigations

  • Work closely with production and service departments

  • Organize standards and maintain current version of standards.

Minimum Job Qualifications (unless otherwise noted):


  • Associates degree or equivalent work experience (2 years minimum)

  • Previous quality experience preferred 

  • Minimum 2 years related experience and/or training in medical device organizations

  • Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.

Education:


  • Associates Degree or equivalent work experience (2 years minimum)

Physical and Environmental Requirements:


  • Normal office environment

  • Proficient use of office equipment: computers, copiers, fax machines and telephones

  • Ability to communicate effectively via spoken, written and electronic means

  • Ability to sit for extended periods of time

Zynex Offers Exceptional Benefits (Full-Time Staff):


  • Health, Dental and Vision Insurance

  • 401K

  • Monthly Health/Wellness Benefit

  • Paid Holidays

  • Paid Time Off (PTO)