Quality Engineer I, Medical Devices | 25% Travel

NCBioImpact; Morrisville (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Teleflex Incorporated is seeking a Quality Engineer 1 to join our Global Operations team in North Carolina. This role supports the Product Quality Assurance team by analyzing post-market data and investigating potential device quality issues for commercialized devices.

You will work cross-functionally with Manufacturing, R&D, Regulatory and other groups to document issues, track metrics, and prepare technical reports.

Qualifications

• BS Degree in Engineering (or related technical field).
• 0-2 years related medical device experience.

Responsibilities

• Create, investigate and manage nonconformances and associated ship holds.
• Investigate, compile and report information for field actions and product removals.
• Collaborate with Manufacturing, R&D, Suppliers, QA, Marketing, Design Assurance, Regulatory.
• Analyze product quality metrics for leadership presentations.
• Apply basic statistics to identify trends from bench and field data.
• Provide clear technical reports and assist external communications as needed.
• Assist during regulatory inspections and audits.
• Use SAP, Agile and other systems for data entry and records.
• Escalate quality issues to QA Manager and other stakeholders.
• Adhere to Teleflex Code of Ethics and policies.

Skills

Statistical software

Excel

Word processing

PowerPoint

Communication

Education

BS in Engineering

Tools

SAP

Agile

Job description

Teleflex Incorporated is seeking a Quality Engineer 1 to join our Global Operations team in North Carolina. This role supports the Product Quality Assurance team by analyzing post-market data and investigating potential device quality issues for commercialized devices.

You will work cross-functionally with Manufacturing, R&D, Regulatory and other groups to document issues, track metrics, and prepare technical reports.