Quality Engineer Job at Alexander Technology Group, Portsmouth, NH

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  • Alexander Technology Group
  • Portsmouth, NH

Job Description

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area.

This is full-time (perm)

On-site in Portsmouth, NH

Key Responsibilities:

  • Develop and maintain quality systems for combination products.
  • Ensure compliance with FDA, ISO 13485, cGMP, and other standards.
  • Lead risk assessments, root cause analyses, and corrective actions.
  • Oversee testing, validation, and documentation processes.
  • Collaborate with R&D, manufacturing, and regulatory teams.
  • Conduct training on QA practices and support continuous improvement.
  • Perform inspections and product testing to ensure quality standards.

Qualifications:

  • Bachelor’s in Engineering, Life Sciences, or related field.
  • Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA).
  • Excellent problem-solving and communication skills.
  • Able to work independently in a small team environment.

Preferred:

  • Experience with design control, eQMS, and statistical tools.
  • ASQ CQE certification.
  • 3+ years in QA/QE roles with combination products.

If interested, please send resume to Jpolombo@alexandertg.com

Job Tags

Permanent employment, Full time,

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