Quality Assurance Specialist

STRATA Skin Sciences, Inc.; Carlsbad (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

STRATA Skin Sciences, Inc. is seeking a Quality Assurance Specialist for a full-time, on-site role in Carlsbad, CA.

The position focuses on maintaining quality across medical device operations, reviewing production records, and ensuring compliance with GMP and regulatory requirements. The role includes executing QC checks, supporting CAPA activities, participating in internal audits, updating SOPs, and driving continuous quality improvements in collaboration with manufacturing, engineering, and

Qualifications

• Experience in QA/QC within medical devices or regulated industries.
• Experience maintaining documentation, SOPs, and CAPA processes.
• Familiarity with GMP standards and application in production/quality.
• Experience conducting internal or supplier audits.
• Bachelor’s degree in a sciences is a plus.
• Ability to interpret technical docs and regulatory requirements with attention to detail.

Responsibilities

• Monitor and maintain quality standards across medical device operations.
• Review production records and associated documentation.
• Support CAPA investigations and participate in internal audits.
• Update and implement SOPs; reinforce GMP adherence.
• Collaborate with manufacturing, engineering, and regulatory teams to drive improvements.

Skills

Quality Assurance

Quality Control

CAPA

GMP

Auditing

Documentation

Cross-functional collaboration

Regulatory interpretation

Continuous improvement

Education

Bachelor's degree in a science

Tools

Quality management software

Job description

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.