Quality Specialist - Product Complaints
$71,000–$104,600 year
On-site · San Diego, California, United States
Job Summary
Post-market QA role focused on monitoring and handling product complaints for Hologic’s molecular diagnostic products. Responsibilities include receiving and processing complaints per SOPs and regulatory requirements, performing initial assessments and investigations (root cause analysis, risk assessment, lab testing support), identifying and escalating adverse events, assisting with regulatory reports (FDA MDR, EU Vigilance), data trending of quality metrics, supporting audits, and contributing to process improvements and training. Strong knowledge of FDA QSR/ISO 13485 and ability to communicate findings across cross-functional teams is required. B.S. in a scientific or engineering field and 3+ years in a related quality role are preferred.
Required Qualifications
- B.S. in scientific or engineering discipline
- 3+ years of experience in a quality role within an ISO 13485 quality management system, ideally with focus on Post-Market Surveillance, complaint handling, and / or complaint trending
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