Supplier Quality Engineer

The Supplier Quality Engineer at Cook Inc. is involved in supplier qualification and monitoring of supplier quality.

Responsible for quality activities related to selecting, developing and maintaining suppliers including:

- Lead supplier audits including pre-audit supplier research, planning/coordination, report writing, and audit finding follow up.
- Qualify new suppliers.
- Evaluate supplier change requests.
- Generate Supplier Corrective Action Requests (SCARs) including issuance, evaluation, and effectiveness monitoring as required and follow up with Suppliers for completion/closure.
- Support Incoming Quality Inspection in changes and supplier nonconformances.
- Monitor quality performance of suppliers .
- Negotiate quality agreement terms.
- Act as liaison between suppliers, engineering, and manufacturing.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

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

• Knowledge of Cook product lines/usage preferred
• Knowledge of Cook quality system and associated documentation preferred

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• 20-30% travel required