Supplier Quality Engineer

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

Job Title: Supplier Manufacturing Engineer

Duration: 12+ Months (Possible temp to hire)

Location: Maple Grove, MN 55311

Hybrid Role

Responsibilities:

• Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product.
• This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.
• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Education/Experience:

• 2-5 years of experience in a manufacturing environment.
• Problem solving, being able to showcase examples
• Manufacturing experience
• Ability to travel up to 15% of the time. (Domestic possible.)

Preferred qualifications:

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device Field.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Excellent communication and project management skills.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.