Quality Control Analyst

Quality Control Analyst II (On-Site)

Location: Carlsbad, CA
Schedule: Monday–Friday (Full-Time; standard business hours, on-site)
Compensation: $75,900 – $86,200 annual base salary (determined by experience, skills, and internal equity)

About Lumos Diagnostics

Lumos develops, manufactures, and distributes innovative diagnostic products — delivering actionable information, in real time, at the point of care.

Our Quality team plays a critical role in ensuring products are released only when they meet defined specifications and regulatory requirements. We operate in a highly regulated manufacturing environment, and this role is designed for professionals who already have hands-on Quality Control experience and are ready to execute independently.

Our culture is guided by our CORE values, which define how we work and lead:

• Take Ownership
• Engage Openly
• Act with Integrity
• Move Together

About the Role

We are seeking a Quality Control Analyst II to join our on-site team in Carlsbad, CA.

This role focuses on executing Quality Control activities, including inspections, laboratory testing, and documentation, to support product release and ongoing compliance. It is best suited for candidates who have prior experience performing QC work in a regulated environment and are comfortable operating within established procedures, documentation requirements, and quality systems.

Working in an ISO 13485 and FDA Quality System Regulation (QSR) environment, you will support product release activities, investigations, audits, and the maintenance of the Quality Management System (QMS). Success in this role requires accuracy, consistency, and the ability to manage quality responsibilities in a fast-paced manufacturing setting.

Key Responsibilities

• Perform inspections and laboratory testing of raw materials, in-process materials, and finished products.
• Generate and document non-conformance reports and support investigations.
• Maintain quality metrics, data analysis, and trending to monitor product and process performance.
• Participate in internal and external audits and regulatory inspections.
• Assist in supplier quality monitoring and documentation review for accuracy and compliance.
• Support complaint investigations and CAPA activities as assigned.
• Contribute to the continuous improvement of the Quality Management System (QMS).

What We're Looking For

This role requires prior Quality Control or laboratory experience in a regulated manufacturing environment. Candidates should be comfortable performing QC testing, inspections, and documentation as part of their current or recent role.

Minimum Qualifications

• Bachelor's degree or equivalent relevant experience.
• 2–4 years of quality control or laboratory experience in a regulated environment (medical device, biotech, or life sciences).
• Strong understanding of cGMP, ISO 13485, and FDA Quality System Regulations.
• Excellent documentation skills and attention to detail.
• Proficiency with Microsoft Office and general lab or database software.
• Strong organizational and communication skills.

Preferred Qualifications

• Experience supporting CAPA, internal audits, validation, or supplier quality processes.
• ASQ certifications (CQI, CQA, or similar) are a plus.

Why Join Lumos Diagnostics

• Be part of a mission-driven company improving healthcare through innovation.
• Work in a regulated environment where Quality Control is critical to product release.
• Join a collaborative team guided by accountability, integrity, and consistency.
• Comprehensive benefits package including medical, dental, vision, life insurance, disability coverage, 401(k) with employer match, paid vacation, and holidays.

How to Apply

To be considered for this position, please submit your resume and ensure all application questions are fully answered. Incomplete applications may not be reviewed.

Pay: $75, $86,200.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending