Supplier Quality Engineer

Entegee; Maple Grove (MN); On-site; USD 70,000 - 95,000; Full time

Job summary

Entegee is seeking a quality-focused professional in Maple Grove, MN to lead supplier remediation activities for manufacturing processes, validations, and quality improvements. You will review PFMEAs, drive corrective actions, and coordinate with suppliers and internal teams to close quality gaps, ensuring adherence to all quality requirements.

The role requires a Bachelor's in Engineering, 2–5 years manufacturing experience, and travel up to 15%.

Qualifications

• Bachelor's degree in Engineering.
• 2–5 years of manufacturing experience.
• Problem-solving, validation, and change management experience.
• Ability to travel up to 15%.

Responsibilities

• Review and remediate supplier PFMEAs and validation documentation.
• Lead change management and corrective remediation activities.
• Collaborate with suppliers and internal teams to resolve quality gaps.
• Ensure compliance with quality requirements.

Skills

Problem-solving

Validation

Change management

Travel readiness

Education

Bachelor's degree in Engineering

Tools

PFMEA

Six Sigma

IQ/OQ/PQ

Statistics

Job description

Overview:

Lead supplier remediation activities involving manufacturing processes, risk documentation, validations, and quality improvements.

Responsibilities:

• Review and remediate supplier PFMEAs and validation documentation.
• Lead change management and corrective remediation activities.
• Collaborate with suppliers and internal teams to resolve quality gaps.
• Ensure compliance with quality requirements.

Requirements:

• Bachelor's degree in Engineering required.
• 2–5 years of manufacturing experience.
• Problem-solving, validation, and change management experience.
• Ability to travel up to 15%.

Preferred:

• Medical device and supplier experience.
• IQ/OQ/PQ and TMV experience.
• Knowledge of PFMEA, statistics, and Six Sigma.