What are the responsibilities and job description for the Quality Engineer position at Alexander Technology Group?
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
