Collins McNicholas

  • Assesses potential new suppliers and service providers for technical quality and quality systems capabilities. Determines method of evaluation and forwards either a correspondence questionnaire to the supplier or conducts an on-site audit.
  • Prepares and audit report that establishes the outcome of the audit and details the non-conformances identified during the on-site audit. Works closely with suppliers to obtain an appropriate written corrective action response plan with estimated dates for completion. Tracks audit results, including corrective actions and provides follow-up to these actions, as required.
  • Evaluates Exception Reports (ERs) issued for nonconforming supplied material and prepares Supplier Corrective Action Requests (SCAR) to effect resolution of root cause problems contributing to unsatisfactory supplier quality performance.
  • Maintains an active role with new products development teams to assist in supplier selection and approval and provide support, as required. Applies the appropriate engineering discipline to assure acceptable products or services and to resolve quality issues.
  • Prepares data for presentation at the Corrective and Preventive Action (CAPA) meetings summarizing the results and status of corrective and preventive actions initiated with suppliers to strive for improvement.
  • Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification/validation and provides assistance in these efforts, as appropriate.
  • Conducts field visits of supplier sites to bring understanding and resolution of quality problems.
  • Uses computer software to measure, track and trend supplier quality performance and provide feedback to the organization and to the supplier for continuous improvement.
  • Conducts certification activities to upgrade approved suppliers to certified supplier status.
  • Notifies suppliers of customer complaints related to device failures resulting from supplied material and requires investigation and corrective action.

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