Overview
Quality Engineer Jobs in Portsmouth, NH at Alexander Technology Group
Title: Quality Engineer
Company: Alexander Technology Group
Location: Portsmouth, NH
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]
