QUALITY ANALYST
Our client is a growing organization operating within the medical equipment and biomedical services industry, supporting healthcare providers in a highly regulated environment.
As the organization continues to grow, it is making a significant investment in strengthening its quality infrastructure and advancing toward ISO 13485:2016 certification. This includes building scalable systems, processes, and documentation that support quality, compliance, operational excellence, and long-term growth.
The organization is committed to developing a Quality Management System that goes beyond audit readiness—one that becomes fully integrated into how the business operates every day.
This is an exclusive search being conducted by Light Source on behalf of our client. The organization's identity will be shared with qualified candidates during the interview process.
The Quality Analyst will play an important role in supporting the development, implementation, and ongoing maintenance of the organization's Quality Management System (QMS), with a primary focus on achieving and maintaining compliance with ISO 13485:2016.
Working closely with quality leadership and cross-functional teams, this position will help ensure quality processes, documentation, records, training, corrective actions, and operational practices are appropriately controlled, consistently followed, and aligned with applicable quality and regulatory requirements.
The Quality Analyst will also support certification-readiness activities, internal audits, CAPA management, document control, quality reporting, supplier quality, and continuous improvement initiatives.
This role is ideal for someone who takes pride in bringing structure, accuracy, and accountability to quality systems and wants the opportunity to make a meaningful impact as an organization builds and matures its quality infrastructure.
Support the implementation, maintenance, and continuous improvement of the organization's QMS in alignment with ISO 13485:2016
Assist in identifying gaps between current business processes and QMS requirements
Support ISO certification-readiness activities, including documentation reviews, gap assessments, internal audits, and corrective actions
Help ensure established quality procedures are effectively implemented and followed across applicable departments
Partner cross-functionally to integrate quality requirements into day-to-day business operations
Maintain and organize controlled QMS documentation, including SOPs, work instructions, forms, policies, and quality records
Coordinate document creation, review, approval, revision, distribution, and archival processes
Help ensure employees are working from current and approved versions of controlled documents
Maintain accurate, organized, and audit-ready quality records
Support continued development and improvement of document-control practices
Assist with the documentation, investigation, tracking, and closure of Corrective and Preventive Actions (CAPAs)
Support root-cause investigations and corrective action planning
Track quality issues, nonconformances, observations, findings, and associated action items through completion
Assist in evaluating the effectiveness of implemented corrective actions
Help identify recurring issues and opportunities for preventive action and process improvement
Support the development and execution of the internal audit program
Assist with audit preparation, evidence gathering, documentation review, and follow-up activities
Track audit findings and ensure assigned corrective actions are appropriately documented and completed
Support preparation for ISO 13485 certification activities
Help maintain continuous readiness for certification and future surveillance audits
Collect, monitor, and analyze quality-related data and key performance indicators
Identify trends, recurring issues, process gaps, and opportunities for improvement
Prepare quality reports, dashboards, and supporting documentation for management review
Maintain trackers for CAPAs, nonconformances, audits, training, document control, supplier quality, and other applicable QMS activities
Support data-driven quality and continuous improvement initiatives
Support QMS and quality-related employee training
Maintain accurate training documentation and records
Help ensure employees understand applicable SOPs, work instructions, and individual quality responsibilities
Assist with tracking required training and completion status
Promote a culture of quality, accountability, documentation
Support supplier qualification, evaluation, and ongoing monitoring activities as applicable
Assist with maintaining supplier quality documentation and records
Work cross-functionally to help ensure operational processes consistently meet established quality requirements
Support risk-based evaluations of processes, suppliers, and quality issues
Assist with identifying and addressing supplier-related quality concerns
Bachelor's degree in Quality, Engineering, Life Sciences, Business, Healthcare, or a related field preferred
2+ years of experience in Quality Assurance, Quality Systems, Regulatory Affairs, Compliance, or a related function preferred
Experience within the medical device, healthcare, biomedical, life sciences, or another regulated industry strongly preferred
Working knowledge of ISO 13485:2016 strongly preferred
Experience with QMS documentation, document control, CAPA, internal audits, nonconformances, and/or quality records
Strong analytical, organizational, and documentation skills
Exceptional attention to detail and commitment to maintaining accurate records
Strong written and verbal communication skills
Ability to manage multiple priorities and work effectively across departments
High level of discretion when handling confidential or sensitive information
Proficiency with Google Workspace
Experience with electronic Quality Management Systems (eQMS) is a plus
Experience supporting an organization through ISO 13485 implementation or certification is highly desirable
Internal auditor training or hands-on internal audit experience is preferred
Familiarity with root-cause analysis and CAPA methodologies
Knowledge of risk-management principles within a regulated environment
Experience developing or maintaining SOPs, work instructions, forms, and controlled records
Familiarity with medical equipment, biomedical services, medical devices, or healthcare technology management is a plus
Office-based on-site in Garden Grove, CA
Regular collaboration with leadership and cross-functional operational teams
Work within a growing organization actively developing and strengthening its quality systems
May participate in internal, certification, and surveillance audit activities as required
Base Salary: $27.50 - $29.50 per hour
Benefits include:
Medical, dental, and vision coverage
401(k) / retirement benefits
Paid time off and paid holidays
Professional development and growth opportunities
We want to understand you, not just your resume.
To apply, please submit:
Your current resume
A brief note sharing why this opportunity interests you and highlighting any experience you have with ISO 13485, Quality Management Systems, CAPA, internal audits, document control, or certification readiness
Applications will be reviewed on a rolling basis until the position is filled.
This is an exclusive search being conducted by Light Source on behalf of our client. Qualified candidates will be contacted directly by the Light Source recruiting team. Additional information regarding the organization will be shared with selected candidates as they progress through the interview process.
All candidate inquiries and information will be handled with appropriate discretion and confidentiality.
We look beyond the resume to understand the person, the experience, and the potential behind it.
Our client provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.
