732-661-0400

Engineer, Quality

  • Location: Dallas, TX
  • Type: Contract
  • Job #36437

Quality Engineer – Hiring immediately!

Biotechnology Company – Plano, TX

M – F: 8am – 5pm

Work with a global healthcare leader who works with leading businesses and products in diagnostics, medical devices, nutraceuticals, as well as generic medicines.

Seeking a talented Engineer who can initiate QA activities and support device complaint investigation and failure analysis as needed. Experience with ISO13485 and FDA or international standards is highly preferred.

Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Provide support to Quality Inspectors as it relates to product acceptance activities
  • Manage the sterilization process, including validations and product sterile loads.
  • Complete final acceptance activities.
  • Provide day to day manufacturing support as a Quality Engineer Lead on nonconformance material investigations and customer complaints on returned product.
  • Lead and participate in problem solving including CAPAs, yield improvements, equipment downtime
  • Manage corrective action and quality improvement activities.
  • Assist in the performance of quality system internal auditing.
  • Establish, monitor, and evaluate quality system metrics.
  • 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.
  • Support quarterly management review meetings.

Preferred Qualifications:

  • Experience in a GMP environment dealing with FDA regulations.
  • Experience or familiarity with ISO13485
  • Degree in Engineering, Chemistry, Biology, Life Sciences or related field.
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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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