Post-Market QA Leader — Medical Devices

Advita Ortho, LLC; Gainesville (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

Advita Ortho, LLC seeks a Manager QA for Post-Market in Gainesville, FL to lead the Post-Market QA team, manage complaint handling and adverse event reporting, and ensure global regulatory compliance. You will coordinate recalls and training across distributors and internal teams.

The role requires a Bachelor’s degree plus at least 7 years in global medical device QMS and adverse event reporting, with strong technical writing and QA tool proficiency.

Qualifications

• Minimum 7 years of global medical device quality management experience.
• Minimum 7 years' experience in global adverse event reporting.
• Experience in complaint trending and trend analysis.

Responsibilities

• Lead and manage the Post-Market QA team for complaints handling and trending.
• Oversee adverse event reporting per federal and international regulations.
• Escalate and coordinate product recalls and stock retrievals to ensure regulatory compliance.
• Interface with distributors, sales force, and reps for reporting training and information.
• Communicate post-market surveillance to FDA and international regulators; provide training to personnel and customers.

Skills

People management

Technical writing

Windows tools

Quality Assurance software

Education

Bachelor's Degree

Tools

TrackWise

SmartSolve

Excel

Job description

Advita Ortho, LLC seeks a Manager QA for Post-Market in Gainesville, FL to lead the Post-Market QA team, manage complaint handling and adverse event reporting, and ensure global regulatory compliance. You will coordinate recalls and training across distributors and internal teams.

The role requires a Bachelor’s degree plus at least 7 years in global medical device QMS and adverse event reporting, with strong technical writing and QA tool proficiency.