Quality Engineer Position Available In Rockingham, New Hampshire
Tallo's Job Summary: The Quality Engineer position in Portsmouth, NH, requires developing quality systems for combination products, ensuring FDA, ISO, and cGMP compliance, leading risk assessments and corrective actions, overseeing testing processes, collaborating with teams, and conducting training. Candidates must have a Bachelor's degree in Engineering or Life Sciences, knowledge of regulatory requirements, and strong problem-solving skills. Experience with design control, eQMS, and ASQ CQE certification is preferred. Interested applicants can send resumes to Jpolombo@alexandertg.com.
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
