Analyst II (Post-Market Complaints)

About the role

The Analyst II is responsible for investigating product complaints, analyzing product data, performing risk assessments, determining root causes, and documenting findings to support product quality and continuous process improvement within a regulated medical device environment.

Responsibilities

• Investigate customer product complaints using available product data.
• Review and analyze complaint information to confirm or deny reported issues.
• Perform risk assessments and determine potential root causes.
• Document investigation findings and prepare clear written conclusions.
• Manage a high volume of complaint investigations while meeting quality and turnaround metrics.
• Identify opportunities for process improvements and workflow optimization.
• Collaborate with cross-functional teams to improve complaint handling processes.
• Utilize automated tools and standardized procedures to increase investigation efficiency.
• Avoid non-compliance with quality system and regulatory requirements.

Requirements

• Bachelor's degree in Biomedical Engineering or a related life sciences/engineering field.
• 3-5 years of experience in complaint handling within medical devices, IVD, MDR, or pharmaceutical manufacturing.
• Understanding of Quality Systems, Good Manufacturing Practices (GMP), and regulated environments.
• Strong analytical and critical thinking skills.
• Excellent written communication skills with the ability to produce detailed investigation reports.
• Strong verbal communication and interpersonal skills.
• Excellent organizational and time management abilities.
• Comfortable performing high-volume, detail-oriented investigative work.
• Demonstrated drive, accountability, and ownership.
• Interest in building a career in Quality rather than Research & Development.

Qualifications

• Must be authorized to work in the U.S.

Skills

• Experience supporting complaint investigations for diagnostic or laboratory instruments.
• Experience with risk assessments and root cause analysis.
• Knowledge of blood gas analyzers, in vitro diagnostics (IVD), or related medical technologies.
• Experience identifying process improvement opportunities.
• Ability to mentor or train peers on quality processes.

Pay

Compensation Range: $45-$55/hour W2

Schedule

Hybrid - San Diego, CA (3 days onsite/week minimum)

Benefits

• Eligible for Health, Dental, Vision, 401K