Quality & Manufacturing Engineer
Quality & Manufacturing Engineer
Phoenix, AZ | Full-Time | On-Site
Humabiologics, Inc. is a regenerative medicine company pioneering human-derived biomaterials to advance research and therapeutic innovation. We are seeking a Quality & Manufacturing Engineer to join our growing team in Phoenix, AZ.
Role Description
In this role, you’ll play a key part in supporting our Quality Management System (QMS), implementing Good Manufacturing Practices (GMP), and ensuring operational compliance across manufacturing and laboratory processes. You’ll work closely with suppliers, vendors, customers, and internal teams to help us deliver high-quality biomaterials that directly impact the future of medicine.
What You’ll Do
- Support GMP manufacturing and laboratory operations by monitoring and enforcing the Quality Management System (QMS).
- Assist in the manufacturing of human-derived biomaterials, including preparation, processing, and documentation of production activities in accordance with established SOPs, cGMP standards, and regulatory requirements
- Track and report QMS metrics including training, deviations, CAPAs, change controls, OOS, and audit performance.
- Serve as a system administrator for document management, workflow facilitation, and configuration management.
- Coordinate instructor-led and computer-based training programs for team learning and compliance.
- Support vendor/supplier quality programs by reviewing change notifications, part requests, material specifications, and release documents.
- Assist in internal audits and support external vendor/supplier audits.
- Write, review, and maintain quality system procedures, validation documentation, and training materials.
- Monitor inventory levels of supplies and reagents.
What We’re Looking For
- Bachelor’s degree in Biology, Microbiology, Biomedical Engineering, or related life sciences field.
- 1–3 years of relevant experience in biotech, manufacturing, or testing facilities.
- Strong knowledge of quality systems, document control, and regulatory guidelines (cGMP, FDA, GLP).
- Proficiency in Microsoft Word, Excel, PowerPoint; experience with MasterControl preferred.
- Excellent verbal and written communication skills for cross-functional collaboration.
- Highly motivated, detail-oriented, and capable of working independently or in a team.
- Strong record-keeping and organizational skills.
Why Humabiologics?
At Humabiologics, you’ll be part of a mission-driven team that is shaping the future of regenerative medicine. We value curiosity, perseverance, and teamwork, and provide a collaborative environment where your contributions directly impact scientific innovation. You will gain experience in biotech manufacturing and quality systems that directly impact patient-focused research.
Apply today to join a fast-growing company at the forefront of biomaterials and regenerative medicine.