Supplier Quality Engineer – Elevate Medical Device Quality

Jobvite, Inc.; Salt Lake City (UT); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

HSA

401k with match

Parental leave

Wellness programs

Job summary

Laborie is a world-class medical technology company focused on improving lives by advancing pelvic and gastrointestinal care. We’re seeking a Supplier Quality Engineer to lead supplier evaluation, risk management, and quality systems for our outsourced partners.

You will audit vendors, drive CAPA, support product development, and ensure compliance with ISO 13485 and 21 CFR, collaborating across engineering and supply chain while upholding Laborie’s values.

Qualifications

• Bachelor's degree in engineering or related field with minimum 5 years QA experience.
• Knowledge of ISO 13485 and 21CFR quality systems.
• Experience with internal and external auditing.
• Experience applying statistical methods to quality assurance.
• Read and reference Training Matrix Q620-FRM-03 or equivalent document.

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/monitoring.
• Audit current or future suppliers to ensure compliance with quality system requirements & material specifications; assist with nonconforming materials disposition.
• Issue and provide technical direction to supplier corrective action requests; monitor and report Supplier KPIs and scorecards.
• Assist with QA 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

Risk management

Statistical methods

Quality assurance

Supplier evaluation

Engineering background

Education

Bachelor's in engineering

Job description

Laborie is a world-class medical technology company focused on improving lives by advancing pelvic and gastrointestinal care. We’re seeking a Supplier Quality Engineer to lead supplier evaluation, risk management, and quality systems for our outsourced partners.

You will audit vendors, drive CAPA, support product development, and ensure compliance with ISO 13485 and 21 CFR, collaborating across engineering and supply chain while upholding Laborie’s values.