Strategic Supplier Quality Engineer – Risk, Audits & CAPA

Jobvite, Inc.; Maple Grove (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

Flexible Spending Account

Health Savings Account

401k with company match

Parental Leave

Wellness programs

Job summary

Laborie is seeking a Supplier Quality Engineer to strengthen quality systems for sourced materials. You will identify supplier risks, implement evaluation procedures, and lead audits to assure compliance with quality and material specifications.

You will provide technical direction on supplier corrective actions, support CAPA processes, and collaborate with design teams on risk management and product development initiatives.

Qualifications

• Bachelor's degree in engineering or related scientific field with at least 5 years in quality assurance.
• Knowledge of ISO 13485 and 21 CFR compliant quality systems.
• Experience with internal and external auditing.
• Experience applying statistical methods to quality assurance.
• Ability to read and understand the 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 for compliance to quality system requirements and assist with evaluation of nonconforming materials.
• Provide technical direction on supplier corrective actions and monitor KPI reports and scorecards.
• Support 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

Auditing experience

Statistical methods

Quality assurance

Education

Bachelor's degree in engineering or related scientific field

Tools

ISO 13485 knowledge

Job description

Laborie is seeking a Supplier Quality Engineer to strengthen quality systems for sourced materials. You will identify supplier risks, implement evaluation procedures, and lead audits to assure compliance with quality and material specifications.

You will provide technical direction on supplier corrective actions, support CAPA processes, and collaborate with design teams on risk management and product development initiatives.