Quality Engineer 1, Supplier

americas-cookmedical; Winston-Salem (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Americas Cook Medical is seeking a Supplier Quality Engineer to monitor and maintain supplier quality performance by supporting qualification activities, risk assessments, and nonconformance investigations in a fast-paced healthcare environment.

You will collaborate with cross-functional teams to ensure incoming materials and supplier processes meet quality and regulatory requirements, coordinate supplier qualifications, audits, CAPA teams, and track corrective actions, with up to 20% travel and

Qualifications

• Bachelor's degree or equivalent in a technical discipline or related background.
• Knowledge of quality tools & principles (e.g. risk assessment).
• Knowledge of medical device regulations, standards and guidances.

Responsibilities

• Maintain, assess and monitor supplier quality.
• Coordinate and perform supplier qualification activities.
• Perform Supplier Scorecards and Risk Assessments.
• Collect supplier data.
• Investigate raw material nonconformities.
• Facilitate resolution of raw material nonconformities.
• Conduct and support supplier audits as needed.
• Track and review Supplier Corrective Actions.
• Participate on CAPA teams.
• Review of Supplier Change Notifications or other change control activities related to Supplier Quality.
• Interact effectively with others across the global organization.
• Adhere to safety requirements.
• Maintain punctual attendance.
• Maintain company quality and quantity standards.
• Demonstrate effective oral and written communication skills.
• Solve problems in collaborative and independent work environments.

Skills

Quality tools & principles

Risk assessment

Oral and written communication

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in technical discipline

Job description

Overview

The Supplier Quality Engineer is responsible for monitoring and maintaining supplier quality performance by supporting qualification activities, risk assessments, and nonconformance investigations. This role works cross-functionally to ensure incoming materials and supplier processes meet quality and regulatory requirements.

Responsibilities

• Maintain, assess and monitor supplier quality
• Coordinate and perform supplier qualification activities
• Perform Supplier Scorecards and Risk Assessments
• Collect supplier data
• Investigate raw material nonconformities
• Facilitate resolution of raw material nonconformities
• Conduct and support supplier audits as needed
• Track and review Supplier Corrective Actions
• Participate on CAPA teams
• Review of Supplier Change Notifications or other change control activities related to Supplier Quality
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

Qualifications

• Bachelors degree or equivalent experience in a technical discipline; or experience of such kind and amount as to provide a comparable background
• Knowledge of quality tools & principles (i.e. risk assessment)
• Knowledge of medical device regulations, pertinent standards and guidances

Physical Requirements:

• Works under general office conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Ability to travel up to 20% of the time.