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