Quality Analyst

Job Description

Job Description

QUALITY ANALYST

Location: Garden Grove, CA
Type: Full-Time | Non-Exempt
Reports to: Quality Manager Who We Are

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 Role

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.

What You'll Do ISO 13485 & Quality Management Systems

• 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

Document & Record Control

• 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

CAPA & Nonconformance

• 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

Internal Audits & Certification Readiness

• 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

Quality Data & Reporting

• 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

Training & Compliance

• 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

Supplier & Operational Quality

• 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

Who You Are

• 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

Work Environment

• 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

Compensation & Benefits

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

Application Process

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.

Equal Opportunity Employer

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.