Quality Engineer


Dallas, TX

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 23 days ago

  by    Traci Wilson

This job is no longer available.

A fast-growing company in need of motivated individuals to assist in the expansion of its North American locations. This includes working within a team environment across the facility to investigate, determine root cause, and develop and implement corrective actions. The QA Engineer will also be asked to participate in internal and external audits.

Responsibilities of the Quality Engineer:

  • Serves as a quality representative for product validation, design transfer, risk management, and specification development on assigned product development teams ensuring compliance with global regulations, including FDA Quality System Regulation
  • Responsible for the ISO 13485 and cGMP compliance of the assigned PMI programs.
  • Recommends and implements Quality process improvements with the approval of Quality Manager
  • Recommends and implements Quality process improvements with the approval of Quality Manager
  • Assist in investigations regarding product complaints and corrective/preventive actions.
  • Uses Quality tools such as: CAPA, Root Cause Analysis, Process Capability, elements of a quality system, acceptance sampling, measurement systems, risk analysis, data collection and summarizing process control planning, FMEA
  • Works with customers and suppliers to maintain quality standards

Requirements for the Quality Engineer:

  • Bachelor's Degree in Engineering
  • 5 years of experience in a GMP regulated environment.
  • 5 years of Validation experience gained from Medical Device or Pharmaceutical Manufacturing
  • Working Knowledge of SAP Systems
  • ASQ Certified Quality Engineer (required)

Benefits Package:

  • Medical/Dental Insurance
  • 401k
  • Education Assistance or Tuition Reimbursement
  • Healthcare spending or reimbursement accounts
  • PTO

The salary for the Quality Engineer is $70,000-$80,000


$81K - $ 92K