Quality Assurance Specialist

Company Description STRATA Skin Sciences is a medical technology company focused on developing, commercializing, and marketing advanced solutions for in-office treatment of dermatologic conditions. Drawing on decades of experience, the company delivers an expanding portfolio of best-in-class skin science technologies to dermatology practices. STRATA’s innovative partnership approach supports clinicians in improving treatment options for life-altering skin conditions. Its technologies are used to treat psoriasis, vitiligo, atopic dermatitis, and other chronic skin diseases, helping enhance outcomes for both practices and patients. Role Description The Quality Assurance Specialist is a full-time, on-site role based in Carlsbad, CA . This position is responsible for monitoring and maintaining quality standards across medical device and technology operations, including review of production records, documentation, and procedures to ensure compliance with internal and regulatory requirements. Day-to-day tasks include executing quality control checks, supporting nonconformance investigations, assisting with CAPA activities, and participating in internal audits. The specialist will help maintain and improve the quality management system, update and implement SOPs, and support Good Manufacturing Practice (GMP) adherence throughout the organization. This role collaborates closely with manufacturing, engineering, and regulatory teams to identify quality risks, recommend corrective actions, and drive continuous improvement initiatives. Qualifications Strong knowledge and practical experience in Quality Assurance and Quality Control within medical devices, or related regulated industries. Experience with Quality Management systems, including maintaining documentation, SOPs, and CAPA processes. Working knowledge of Good Manufacturing Practice (GMP) standards and their application in production and quality environments. Experience in Quality Auditing, including planning, conducting, and documenting internal or supplier audits. Bachelor’s degree in a sciences is a plus. Ability to interpret technical documentation, specifications, and regulatory requirements with strong attention to detail. Effective communication and collaboration skills, with the ability to work cross-functionally and present findings clearly. Proficiency with quality and documentation software tools; familiarity with ISO 13485 and FDA regulations is highly beneficial. Demonstrated problem-solving skills and a continuous improvement mindset. #J-18808-Ljbffr