Post-Market Quality Engineer — CAPA & MDR Insights

AgileGrid Solutions; United States; On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Bonus potential

Health insurance

401(k) contributions

Paid time off

Continuing education

Job summary

Medline Industries, LP is seeking a post-market quality professional to independently manage activities that ensure medical device safety, effectiveness, and regulatory compliance. You will evaluate product performance, investigate complaints and adverse events, and lead CAPA initiatives under broad supervision.

The ideal candidate has a Bachelor’s degree in a technical field and at least two years of quality or engineering experience, with strong organizational and analytical skills and the

Qualifications

• Bachelor's degree in engineering, science, mathematics, or related technical field.
• At least two years of experience in quality or engineering.
• Ability to manage objectives with limited supervision and meet deadlines.
• Proficiency with Word, Excel, PowerPoint, Outlook; intermediate Excel skills including formulas, tables, conditional formatting, charts.

Responsibilities

• Manage post-market surveillance activities including complaint trending and adverse event monitoring.
• Conduct complaint investigations to determine reportability, root cause, and corrective actions.
• Support regulatory submissions (MDR, Vigilance) and maintain records for compliance.
• Develop and verify CAPAs addressing immediate risks and systemic causes.
• Collaborate with Regulatory Affairs, Medical Affairs, Operations, and Product Management on safety concerns and field actions.

Skills

Quality management

Regulatory knowledge

Analytical thinking

Project coordination

Problem solving

Education

Bachelor's degree in engineering/science/mathematics

Tools

Microsoft Office

Job description

Medline Industries, LP is seeking a post-market quality professional to independently manage activities that ensure medical device safety, effectiveness, and regulatory compliance. You will evaluate product performance, investigate complaints and adverse events, and lead CAPA initiatives under broad supervision.

The ideal candidate has a Bachelor’s degree in a technical field and at least two years of quality or engineering experience, with strong organizational and analytical skills and the