Product Complaints Analyst II

Hydrogen Group; San Diego (CA); Hybrid; USD 55,000 - 62,000; Part time

Job summary

Hydrogen Group is seeking a Product Complaints Analyst II for a 2.5-month contract in San Diego, CA. The role is hybrid (3 days onsite) with a 8:00 AM-5:00 PM schedule, paying $40.00-$45.00 per hour.

Responsibilities include reviewing customer complaints, supporting cross-functional investigations, and ensuring GMP-compliant records. Ideal candidates will have a Bachelor's degree and 2-5 years of quality/regulatory affairs experience in a medical device or IVD company, with a solid track record

Qualifications

• Bachelor's degree required.
• 2-5 years of quality/regulatory experience in an IVD or medical device company.
• Experience supporting product complaint investigations in regulated environments.

Responsibilities

• Review complaint cases and assess escalation needs to Regulatory Affairs.
• Evaluate and document product complaints, including investigation and containment actions.
• Coordinate cross-functional discussions to document and analyze quality issues.

Skills

Quality Assurance

Regulatory Affairs

Complaint Investigations

Education

Bachelor's degree

Job description

Product Complaints Analyst II

Pay: $40.00-$45.00/hr

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

Duration: 2.5-month initial contract with potential to extend

Schedule: Monday-Friday, 8:00 AM-5:00 PM

The Quality Assurance professional will support product quality and complaint investigation activities for medical device products. This role is responsible for evaluating customer complaints, facilitating cross-functional investigations, documenting and analyzing quality issues, and ensuring customer feedback is appropriately assessed and escalated.

The position will collaborate across functional teams to support complaint investigations, quality escalations, and resulting CAPA activities while ensuring records meet applicable GMP requirements.

Key Responsibilities

• Review individual complaint cases and assess potential adverse events for timely escalation to Regulatory Affairs.
• Evaluate product complaints, including assessment, investigation, containment, review, approval, and escalation determination.
• Facilitate cross-functional discussions to identify, document, analyze, and report product quality issues.
• Ensure complaint records and associated documentation meet GMP standards, including investigations, CAPAs, and nonconformances (NCs).
• Participate in, facilitate, and support complaint investigations and resulting CAPA activities.
• Participate in rotational monitoring of the Quality Assurance escalation mailbox and complete associated tasks.
• Support functional-area quality initiatives and provide assistance to colleagues as needed.
• Complete additional quality-related activities as assigned.

Qualifications

• Bachelor's degree required.
• 2-5 years of recent Quality and/or Regulatory Affairs experience within an in vitro diagnostics (IVD) or medical device company.
• Experience supporting product complaint investigations and quality activities in a regulated environment.