What are the responsibilities and job description for the Manufacturing Quality Technician position at Alexander Technology Group?
The Alexander Technology Group is looking for a manufacturing Quality Engineer provides day-to-day quality support for combination product manufacturing. This floor-facing role ensures materials, equipment, in-process activities, and finished products meet quality, safety, and regulatory standards in a fast-paced production environment.
Key Responsibilities
- Provide on-floor quality support for manufacturing operations and perform line clearances, product changeovers, and labeling checks.
- Conduct incoming inspections and in-process quality checks to ensure compliance with specifications.
- Execute final device testing, troubleshoot issues, and escalate concerns as needed.
- Review batch records for accuracy, completeness, and GMP compliance.
- Support nonconformance investigations, material quarantine, root cause analysis, and CAPA activities.
- Assist with calibration programs and maintain equipment quality documentation.
- Ensure compliance with cGMP, ISO, FDA, and quality system requirements.
- Support audits, validations, change controls, and continuous improvement initiatives
Required:
- Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).
- 2–4 years in regulated manufacturing (pharma, medical device, or combination products preferred).
- Strong attention to detail, documentation, and ability to work in a production environment.
- Working knowledge of quality systems, cGMP, and data integrity.
If interested, please send resume to Jpolombo@alexandertg.com