Quality Assurance Specialist II

At Induce Biologics USA Inc., we are focused on developing and providing advanced technologies for bone regeneration. With a foundation based on science, clinical evidence, and clinical experience, our Natural Matrix Protein® (NMP®) products support healing across a wide range of spine, dental, and orthopedic procedures. By joining Induce Biologics USA Inc., you’ll be part of a mission-driven team working with revolutionary technology that’s reshaping the future of bone regeneration and making a real difference in patients’ lives. A Quality Assurance Specialist II will play a critical role in maintaining and improving our Quality Management System while supporting regulatory compliance, product quality, and continuous improvement initiatives across the organization. What You'll Do Lead and coordinate key workflows within our electronic Quality Management System (eQMS), including: Document & Change Control Training Management CAPA Equipment Management Support eQMS migration, validation, configuration changes, and continuous improvements. Conduct Quality Assurance reviews and approvals for batch records, deviations, equipment documentation, supplier assessments, and product release activities. Coordinate and support internal audits, external audits, regulatory inspections, and accreditation activities. Serve as a designated Quality Assurance Trainer. Support supplier qualification and ongoing monitoring activities. Facilitate change implementation, verification, and validation activities. Partner cross-functionally to ensure compliance with cGMP, cGTP, and applicable regulatory requirements. What We're Looking For Bachelor's degree in Engineering, Biology, Chemistry, Manufacturing, or a related scientific discipline. 5+ years of experience in Quality Assurance within: Human Tissue Processing Medical Device Biologics Pharmaceutical or Biotechnology Manufacturing Preferred Experience Orthopedic, Spine, or Foot & Ankle implantable products. Ideal Candidate We're looking for someone who: Has strong knowledge of cGMPs, cGTPs, and FDA regulatory requirements. Thrives in a fast-paced, highly regulated environment. Is experienced with eQMS platforms, ERP systems, and Microsoft Office. Can effectively influence and collaborate across cross-functional teams. Is highly organized, analytical, and solutions-oriented. Has excellent written and verbal communication skills. Demonstrates ownership, accountability, and a passion for quality. Enjoys collaborating in person and is able to work onsite Monday through Friday in our Irvine office. Why Induce Biologics? At Induce Biologics, we're committed to advancing regenerative medicine through innovation, quality, and collaboration. If you're looking for an opportunity to make a meaningful impact while working alongside a talented and mission-driven team, we'd love to hear from you. For California, the base salary range for this position is $100,000 - $125,000. The pay for the successful candidate will depend on various factors (e.g., qualifications, skills, education, previous experience). Induce Biologics participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the United States. #J-18808-Ljbffr