Process Assurance Quality Engineer

Stark Pharma Solutions Inc
North Carolina

Position: Process Assurance Quality Engineer
Location: Shelby, NC (100% On-Site)
Citizenship Requirement: US Citizen Only

Experience: 6 - 8 Years
Duration: 12+ Months

Role Overview

We are seeking a Process Assurance Quality Engineer with strong expertise in electronics quality to support manufacturing and production compliance for worldwide distribution. This role involves designing, implementing, and maintaining quality assurance protocols, ensuring adherence to safety, regulatory, and internal standards. The engineer will oversee inspection and testing methods, evaluate production processes, and drive compliance with industry frameworks such as GLP, GMP, ISO, Six Sigma, DO-254, and DO-178C.

Key Responsibilities
  • Develop, apply, and update quality standards for receiving, in-process, and final inspections.

  • Review and evaluate in-process rejections, determine dispositions, and implement corrective actions.

  • Support internal and external audits.

  • Interface with customers, vendors, and cross-functional teams to resolve quality issues and provide technical information.

  • Provide technical support to inspection teams on mechanical and electronic hardware.

  • Prepare and deliver product/process assurance documentation for customer programs.

  • Conduct risk analysis and mitigation using PFMEA, Control Plans, and Measurement System Analysis.

  • Perform quality assurance tasks for electronic hardware and software in compliance with DO-254 and DO-178C requirements.

Qualifications
  • Bachelor's degree in Engineering, Quality, or equivalent experience.

  • Internal Lead Auditor Certification; LEAN/Six Sigma Green Belt (or equivalent).

  • Strong communication skills (oral and written) with proficiency in MS Office.

  • 2+ years in a technical engineering environment.

  • 2+ years of experience with DO-254 hardware development .

  • 2+ years of experience with DO-178C software development .

  • 2+ years acting as a Quality Assurance Engineer in a DO-254 or DO-178C environment.

  • Practical hands-on experience in electronics hardware and software process assurance.

  • Experience with APQP/PPAP (PFD, PFMEA, Control Plans, etc.) is a plus.

Posted 2025-08-19

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