Senior Supplier Quality Engineer
The position is reporting to the Director of Quality, is responsible for the management and development of our Suppliers. This includes supplier quality system implementation and maintenance, supplier audits, non-conforming materials and supplier and component risk management activities. The Supplier Quality Engineer leads supplier development initiatives and is a technical resource for the materials, manufacturing, and quality departments with regards to supplier development and supplier process evaluation.
* Develops, evaluates, and maintains supplier processes.
* Leads supplier selection, evaluation and re-evaluation processes.
* Lead supplier approval and qualification of new/revised materials and services which includes inspection method development and validation as well as correlation with supplier's methods.
* Work with suppliers to apply process capability studies and understand and evaluate material manufacturing processes.
* Works closely with the supplier to sustain and improve product quality.
* Performs periodic supplier audits and risk assessments.
* Manages nonconforming materials process.
* Leads Material Review Board and oversees disposition of discrepant material and devises process to assess product quality and reliability.
* Performs failure analysis and corrective and preventive actions related to suppliers.
* Prepares quarterly reports of Supplier Quality for management review.
* Other responsibilities as assigned
* BS degree in engineering or relevant discipline.
* Minimum of 5 years Supplier Management and Development experience in a manufacturing environment.
* Working knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDR and ISO 14971 as well as associated standards for verification and validation techniques
* ISO lead auditor certification or equivalent is preferred.
* Experience with manufacturing and production processes and engineering principles.
* Ability to provide guidance to improve process efficiency.
* Self-motivated, "hands-on", able to work in a team and small company environment, ability to accomplish multiple assignments simultaneously.
* Very detailed and analytically oriented.
Other preferred experience
* Software and Equipment validation/qualification
* Part 11 compliance
* AQR lead auditor certification
The anticipated salary range for this role is $90,000-$130,000/yr. The salary range may flex based on experiene and the client's needs.