Post Market Quality Specialist 2

The Post Market Quality Specialist performs statistical analysis of complaint and post market data for assigned Hologic product families, identifying trends, emerging signals, and opportunities for quality improvement. The role maintains and reconciles PMS datasets, contributes complaint data for required PMS documentation, and serves as the primary point of contact for complaint related analytics.

Requirements

• Bachelor's degree in Engineering, Science, or related technical field
• 3+ years in post market quality, complaint handling, quality engineering, or similar analytical role. Medical device experience preferred
• Strong analytical and statistical skills; experience identifying trends and early warning signals
• Working knowledge of FDA 21 CFR 820.198, ISO 13485, ISO 14971, and EU MDR PMS requirements
• Strong communication skills for presenting data to cross functional teams and leadership
• Effective organization, prioritization, and problem solving skills
• Computer skills: Microsoft Office, Minitab, Oracle, Agile and Salesforce (H1)

Benefits

• Paid Time Off
• 401k Matching
• Retirement Plan