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 [email protected]

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