Quality Engineer - Medical Devices & Process Improvement

AtriCure, Inc.; United States; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental from day 1

401K with match

Parental Leave

Volunteer Time Off

Pet Insurance

On-site fitness center

Job summary

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure product quality, risk management, and regulatory compliance across the lifecycle. You will lead cross-functional activities, manage NCRs, CAPAs, and validations, and contribute to process improvements.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 2-5 years in a process, manufacturing, or quality engineering role.
• Able to interpret drawings (GD&T) and product specs.
• FDA and ISO 13485 knowledge.

Responsibilities

• Provide daily Quality Engineering support in manufacturing operations with cross-functional teams.
• Coordinate activities across Engineering, Manufacturing, Supplier Quality, Inspection, and Document Control (NCR, Investigation, FMEAs, Rework, Deviations, CAPA).
• Chairs the MRB for respective product line.
• Lead risk management activities including pfMEAs and health hazard evaluations.
• Analyze quality metrics and process performance to drive improvements.

Skills

Communication skills

Problem solving

Collaboration

Organizational skills

Lean tools awareness

Education

Bachelor's degree in Engineering

Tools

Gage R&R

FMEA

CAPA

Statistical analysis

Job description

AtriCure, Inc. is seeking a Quality Engineer to support manufacturing operations and product lifecycle management.

You will collaborate with Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure product quality, risk management, and regulatory compliance across the lifecycle. You will lead cross-functional activities, manage NCRs, CAPAs, and validations, and contribute to process improvements.