Supplier Quality Engineer: Risk & Audit Leader

Laborie Medical Technologies Corp; Plymouth (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision insurance

Health Savings Account

401k Retirement Plan with CompanyMatch

Parental Leave

Wellness Programs

Job summary

Laborie Medical Technologies Corp in Plymouth, MN is seeking a Supplier Quality Engineer to manage quality of materials from suppliers and contract manufacturers. You will implement supplier evaluation procedures, use risk management tools, and drive supplier performance through audits and KPIs.

You will collaborate with design and manufacturing teams, support CAPA, internal audits, and product development risk assessments to ensure compliance with ISO 13485 and 21 CFR requirements.

Qualifications

• Bachelor's degree in engineering or related field with 5+ years in quality assurance.
• Experience with ISO 13485 and 21 CFR compliant systems.
• Auditing experience, internal and external.
• Ability to read and understand Training Matrix Q620-FRM-03 or equivalent.

Responsibilities

• Identify and manage risks of supplied materials and implement supplier evaluation procedures.
• Use risk management tools to mitigate supplier risks and participate in supplier selection and monitoring.
• Audit current or future suppliers for compliance and disposition of nonconforming materials.
• Issue supplier corrective action requests and monitor KPI reports.
• Support QA processes such as internal auditing, complaint handling, CAPA fulfillment.
• Participate in product design and development projects with engineering risk management input.

Skills

Quality assurance

Auditing

Risk management

Statistical methods

Education

Bachelor's degree in engineering

Job description

Laborie Medical Technologies Corp in Plymouth, MN is seeking a Supplier Quality Engineer to manage quality of materials from suppliers and contract manufacturers. You will implement supplier evaluation procedures, use risk management tools, and drive supplier performance through audits and KPIs.

You will collaborate with design and manufacturing teams, support CAPA, internal audits, and product development risk assessments to ensure compliance with ISO 13485 and 21 CFR requirements.