Supplier Quality Engineer

Intellectt Inc; Utah; On-site; USD 80,000 - 100,000; Full time

Job summary

A reputable medical device company in Draper, Utah, is seeking an experienced Supplier Quality Engineer to support supplier quality management and address backlog issues. The ideal candidate should have 5-10 years of relevant experience, particularly in managing Supplier CAPAs, and a solid understanding of FDA QSR and ISO 13485 standards. This role requires excellent communication skills and a hands-on approach to problem-solving within a regulated environment.

Qualifications

• 5–10 years of Supplier Quality experience within the medical device industry.
• Proven experience managing Supplier CAPAs, SCARs, NCRs, and supplier investigations.
• Strong ability to engage suppliers and independently drive corrective action activities.

Responsibilities

• Perform triage and prioritization of aging supplier quality records.
• Lead supplier investigations including root cause analysis.
• Manage, track, and close Supplier CAPAs, SCARs, NCRs, and NOCs.

Skills

Supplier quality management

Root cause analysis

CAPA execution

Strong communication skills

Job description

Location: Draper, UT (Greater Salt Lake City Area)

Duration: 9-Month Contract

Position Overview

We are seeking an experienced Supplier Quality Engineer to support a medical device client in Draper, Utah. This role is focused on addressing a backlog of aging supplier quality records and driving timely closure of open quality activities.

The ideal candidate will bring strong, hands-on experience in supplier-facing investigations, root cause analysis, and CAPA execution within a regulated medical device environment. This is a highly independent, execution-driven role requiring close collaboration with suppliers to resolve quality issues efficiently and compliantly.

Key Responsibilities

• Perform triage and prioritization of aging supplier quality records; develop and execute structured action plans for closure
• Lead supplier investigations, including root cause analysis and implementation of corrective and preventive actions
• Manage, track, and close Supplier CAPAs, SCARs, NCRs, and NOCs
• Work directly with suppliers to drive timely and effective resolution of quality issues
• Support supplier risk assessments and updates to quality documentation
• Ensure ongoing compliance with medical device Quality System requirements (FDA QSR and ISO 13485)
• Identify and drive continuous improvement opportunities within supplier quality processes

Required Qualifications

• 5–10 years of Supplier Quality experience within the medical device industry
• Proven experience managing Supplier CAPAs, SCARs, NCRs, and supplier investigations
• Strong ability to engage suppliers and independently drive root cause and corrective action activities
• Solid working knowledge of FDA QSR and ISO 13485
• Excellent analytical, documentation, and problem-solving skills
• Strong communication and stakeholder-management capabilities

Preferred Qualifications

• Experience in a high-volume manufacturing environment
• Demonstrated success reducing quality backlogs and closing aged quality records
• Experience supporting supplier audits and remediation activities