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.
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