732-661-0400

Engineer, Quality

  • Location: Plano, TX
  • Type: Contract
  • Job #37702

Quality Engineer

Plano, TX

A global healthcare leader is seeking a Quality Engineer that will be responsible to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. This is a great opportunity for an established Quality Engineer with 2-5 years of experience within the healthcare industry, and a minimum of a Bachelors degree in scientific related life science field.

Shift: 8am-5pm, Monday-Friday

Pay: $40-42/hr.

Terms: 6 month contract w/potential for extension

Essential Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor, and evaluate quality system metrics.

**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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