Analyst II; Post-Market Complaints

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Analyst II (Post-Market Complaints), location is Hybrid (San Diego, CA). The start date is ASAP for this 6-month contract-to-hire position.

• Job Title: Analyst II (Post-Market Complaints)
• Location: Hybrid - San Diego, CA (3 days onsite/week minimum)
• Start Date: ASAP
• Duration: 6-month Contract-to-Hire
• Compensation: $45–$55/hour W2
• Benefits: Eligible for Health, Dental, Vision, 401K
• EEO Statement: Must be authorized to work in the U.S. This position is not eligible for sponsorship

• 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.
• Ensure compliance with quality system and regulatory 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.

• 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.