About The Position

As Product Release Quality Assurance Associate or Technician, you will perform documentation review to all device history, associated data, and documentations prior to releasing product. You will ensure products are not available for release until ambiguities and errors are resolved. Authorized person(s) shall issue the product release form as required and approve the release of the finished product, while remaining independent of other functions such as, but not limited to production and inspection. This is a 1st shift position: 7:00am-3:30pm, Monday-Friday

Requirements

  • Ability to follow instructions, both written and oral.
  • Ability to work in a team environment.
  • Professional communication skills.
  • A working knowledge of basic computer skills
  • Ability to apply skills in a manner to ensure proper decisions for acceptance or rejection of goods is imperative.
  • Database management knowledge
  • Ability to work independently
  • High School Diploma or GED
  • Associate: No related experience required
  • Technician: One year of related experience required
  • Visual acuity requirements apply to the role, including peripheral, color, and depth perception.

Nice To Haves

  • Preferred: High School Diploma

Responsibilities

  • Assure inspection is performed in accordance with FDA, ISO, and other applicable regulations / guidelines.
  • Follow written instructions with engineering-based content.
  • Apply attention to detail in documentation.
  • Interface with peers, engineers, and Regulatory auditors.
  • Accurately record data results to ensure proper segregation of accepted and rejected products.
  • Operate under the direction of QC Management team.
  • Develop, update, and maintain Device History Record database
  • Provide Certificate of Conformance (CoC) upon request

Benefits

  • Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO, Employee Assistance Program, Education Assistance
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