Senior Post‑Market Quality Analytics Lead

Hologic, Inc.; Newark (DE); On-site; USD 92,200 - 144,300; Full time

Job summary

A leading medical device company is looking for a Sr. Post Market Quality Specialist to analyze complaint and post market data. This role involves identifying trends, leading Post Market Surveillance Review Boards, and collaborating with Quality Engineers to support investigations. The ideal candidate will have a Bachelor's degree in Engineering or Science, along with over 5 years of experience in quality fields, specifically within medical devices. This position also offers competitive compensation based on experience and market conditions.

Qualifications

• 5+ years in post market quality, complaint handling, quality engineering, or similar analytical role; medical device experience preferred.

Responsibilities

• Perform routine and ad hoc analysis of complaint and post market data.
• Own, schedule, prepare, and present Post Market Surveillance Review Boards.
• Support product investigations in partnership with PQEs and QDEs.

Skills

Strong analytical and statistical skills

Working knowledge of FDA 21 CFR 820.198

ISO 13485 and ISO 14971 knowledge

Strong communication skills

Effective organization and problem-solving skills

Computer skills: Microsoft Office, Minitab

Education

Bachelor’s degree in Engineering, Science, or related technical field

Tools

Minitab

Oracle

Agile

Salesforce

Job description

A leading medical device company is looking for a Sr. Post Market Quality Specialist to analyze complaint and post market data. This role involves identifying trends, leading Post Market Surveillance Review Boards, and collaborating with Quality Engineers to support investigations. The ideal candidate will have a Bachelor's degree in Engineering or Science, along with over 5 years of experience in quality fields, specifically within medical devices. This position also offers competitive compensation based on experience and market conditions.