Supplier Quality Engineer – MedTech Quality & Compliance

Laborie; Salt Lake City (UT); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

Health Savings Account

401k Match

Parental Leave

Wellness Programs

Job summary

Laborie seeks a Supplier Quality Engineer to manage product quality through supplier evaluation, risk management, and auditing. You will work with suppliers to ensure material specifications meet quality standards and support CAPA and KPI reporting.

The role requires a bachelor's degree in engineering or related field and at least 5 years in QA, with experience in ISO 13485 and 21 CFR systems, plus strong auditing and statistical skills.

Qualifications

• Bachelor's degree in an 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 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 & material specifications and assist with evaluation and disposition of nonconforming materials.
• Issue and provide technical direction to supplier corrective action requests and monitor and compile reports for Supplier KPI’s, Scorecards.
• Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment.
• Participate in product design and development projects as needed and provide engineering support to products including risk management activities.

Skills

Quality Assurance

Auditing

Risk Management

Statistical Methods

Regulatory Knowledge

Education

Bachelor's degree in Engineering or related science

Job description

Laborie seeks a Supplier Quality Engineer to manage product quality through supplier evaluation, risk management, and auditing. You will work with suppliers to ensure material specifications meet quality standards and support CAPA and KPI reporting.

The role requires a bachelor's degree in engineering or related field and at least 5 years in QA, with experience in ISO 13485 and 21 CFR systems, plus strong auditing and statistical skills.