Post Market Analyst Lead

Contract Length: 12 months

Pay Rate: $40-$50/hr

Location: Burlingame, CA (onsite, relocation considered)

About the role

Apex Systems is seeking a Post Market Complaint Lead to support wearable technology initiatives. This individual will serve as a key resource for complaint management, post-market surveillance (PMS), complaint trending, and customer quality activities supporting regulated consumer technology products. The Complaint Lead will focus on Hearing Enhancement complaint management and serve as a primary quality contact for complaint investigations, PMS reporting, and issue escalation activities. This role requires a strong understanding of complaint handling processes, root cause investigations, CAPA, and quality system compliance.

Responsibilities

• Lead complaint handling and post-market surveillance activities for Hearing Enhancement products.
• Review, triage, investigate, and resolve product complaints from initiation through closure.
• Manage and oversee first-party (1P) store complaint activities.
• Conduct complaint trending analysis and provide reports to quality leadership.
• Drive root cause investigations and support CAPA development.
• Maintain complaint records and ensure compliance with quality system requirements.
• Support SOP development, process improvements, and quality documentation updates.
• Partner closely with Engineering, Product, Human Factors, Risk Management, and Regulatory teams.
• Provide expertise related to complaint management, PMS, and associated quality processes.

Requirements

• 2-5+ years of experience in Complaint Handling, Post Market Surveillance, Customer Quality, Product Quality, or regulated quality systems.
• Experience conducting complaint investigations and root cause analysis.
• Experience supporting CAPA and quality process improvement activities.
• Strong understanding of quality documentation and compliance requirements.
• Experience presenting complaint trends, metrics, and quality insights.
• Ability to work independently and manage multiple priorities.

Preferred Qualifications

• Experience supporting wearables, hearing enhancement products, consumer electronics, or medical devices.
• Knowledge of ISO 13485, FDA Quality System Regulations, or regulated product environments.
• Experience with complaint management systems, PLM tools, or eQMS platforms.
• Familiarity with risk management and human factors activities.

Benefits

• Supplemental medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program and access to certification prep, technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations including CompTIA and IIBA.
• Dedicated customer service team for consultants and a certified Career Coach.