Lead Supplier Quality Engineer – Med Device CAPA

REQ Solutions; Maple Grove (MN); Hybrid; USD 75,000 - 100,000; Full time

Job summary

REQ Solutions is seeking a Supplier Manufacturing Engineer in Maple Grove, MN, a hybrid role focused on remediation activities for CM SFMD products. You will work with suppliers and internal teams to drive CAPA 7720 initiatives and ensure compliance to risk documentation and validation criteria.

The position requires 2–5 years in manufacturing, strong problem solving and communication skills, and up to 15% travel.

Qualifications

• 2–5 years of experience in a manufacturing environment.
• Strong problem solving with concrete examples.
• Ability to travel up to 15% (domestic).

Responsibilities

• Lead remediation activities for CAPA 7720 on CM SFMD products.
• Collaborate with CM SFMD suppliers and cross‑functional teams to deliver outcomes.
• Review and approve PFMEA to defined criteria and validate processes and inspections.
• Execute change management to address gaps in risk documentation and validations.
• Ensure patient safety and product quality in line with quality policies.

Skills

Problem solving

Communication

Project management

Statistical methods

Six Sigma

Job description

REQ Solutions is seeking a Supplier Manufacturing Engineer in Maple Grove, MN, a hybrid role focused on remediation activities for CM SFMD products. You will work with suppliers and internal teams to drive CAPA 7720 initiatives and ensure compliance to risk documentation and validation criteria.

The position requires 2–5 years in manufacturing, strong problem solving and communication skills, and up to 15% travel.