Strategic Supplier Quality Engineer | Risk, Audits & CAPA

Laborie; Maple Grove (MN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid time off

Volunteer time off

Medical, Dental, Vision

HSA with company contributions

401k with company match

Parental leave

Wellness programs

Job summary

Laborie is seeking a Supplier Quality Engineer to manage supplier performance and quality systems, ensuring materials meet specifications and regulatory requirements. You will lead supplier audits, drive corrective actions, and support risk management across product life cycles.

In this role, you will collaborate with design and manufacturing teams to strengthen supplier controls, monitor KPIs, and contribute to robust quality assurance programs that protect patients and improve outcomes.

Qualifications

• Bachelors' degree in an engineering or related scientific field with at least 5 years in quality assurance.
• Knowledge of ISO 13485 and 21CFR compliant quality systems.
• Experience with internal and external auditing.
• Experience applying statistical methods to quality assurance.
• Must read and understand Training Matrix Q620-FRM-03 or equivalent

Responsibilities

• Identify and manage risks associated with supplied materials and maintain quality system procedures for supplier evaluation.
• Use risk management tools to identify and mitigate supplier risks and participate in supplier selection and monitoring.
• Audit current or future suppliers to ensure compliance to quality system requirements and assist with evaluation and disposition of nonconforming materials.
• Issue and provide technical direction to supplier corrective action requests and monitor supplier KPI reports.
• Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment.
• Participate in product design and development projects and provide engineering support including risk management activities

Skills

Quality assurance

Risk management

Auditing

Statistics

Education

Bachelor's degree in engineering or related field

Job description

Laborie is seeking a Supplier Quality Engineer to manage supplier performance and quality systems, ensuring materials meet specifications and regulatory requirements. You will lead supplier audits, drive corrective actions, and support risk management across product life cycles.

In this role, you will collaborate with design and manufacturing teams to strengthen supplier controls, monitor KPIs, and contribute to robust quality assurance programs that protect patients and improve outcomes.