Robert Duvall Email & Phone Number

Johnstown, On

• Manage (including planning) the audit process to monitor the quality system and compliance with regulatory and customer requirements. • Provide leadership on key manufacturing, customer and vendor issues to ensure compliance and continued product distribution. • Design and maintained ongoing awareness of KPI’s to ensure deadlines and service levels are achieved.• Act as primary customer interface for significant QA related issues/initiatives; coordinate participation of other members of the team to ensure positive customer relationships. • Act as the primary advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues).

Iroquois, On Canada

• Utilized online tools within to direct and obtain approvals for Engineering Change Requests.• In conjunction with manufacturing management, support and directed activities to secure short lead time, flexible manufacturing and supply chain processes targeted to reduce lead times, increase service levels and flexibility and reduce overall costs.• Collected and enter updated manufacturing times from the shop floor. • Ensured completion of manufacturing’s portion of the PPDS process. • Coordinated manufacturing ACER process.• Used Excel, reports and other tools to track actions required.

Brockville, Ontario

• Evaluated and approved new suppliers, fostering long term supplier relationships and performed supplier audits identifying product improvement and cost saving measures ensuring high quality.• Assisted in internal quality audits and CAPA investigations to improve quality and compliance levels.• Ensured deficiencies and discrepancies are completed and reconciled as required prior to product release or disposition. Recommended appropriate corrective actions and follow up to ensure continued product distribution.• Reviewed manufacturing and packaging records to ensure compliance for product release.

Cornwall, On

• Managed (including planning) the audit process to monitor the quality system and compliance with regulatory and customer requirements. • Provided leadership on key regulatory, customer and 3rd part audits to ensure compliance and continued product distribution. • Designed and maintained ongoing awareness of KPI’s to ensure deadlines and service levels greater than 98% were achieved.• Acted as primary customer interface for significant QA related issues/initiatives; coordinate participation of other members of the account team to ensure positive customer relationships. • Acted as the primary advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues).

Morrisburg, On

• Facilitated more than a dozen third party FDA, Health Canada and ISO audits resulting in either one (1) or zero (0) minor non-conformities ensuring continuous product distribution.• Led the configuration, training and implementation of an electronic document control system saving more than $100K per year.• Communicated key quality indicators to management and all employees in a timely manner ensuring continuous improvement and customer satisfaction. • Reviewed and analyzed customer requirements and ISO product standards ensuring a clear and thorough understanding of labeling, packaging, verification and testing maintaining compliance and ensuring on time delivery.• Reviewed and assisted Canadian delegation with development of international dentistry standards as Member ISO TC106.

Morrisburg, On

• Oversee the GMP and ISO system implementation, maintenance and ongoing compliance.• Communicate to management and all employees in a timely manner key quality indicators.• Review and analysis of customer requirements, to ensure a clear and thorough understanding of their labeling, packaging, verification and testing requirements.• Maintain and demonstrate continuing compliance to ISO product standards with inspection and testing of the product and packaging.• Maintain a system to effectively control, issue, recall and archive quality documents.

Morrisburg, On

• Maintained Corrective and Preventive Action Program effectively controlling costs.• Fostered long term supplier relationships, approved new suppliers, communicated clear material specifications and performed supplier audits identifying product improvement and cost saving measures and ensuring high quality.• Administered, maintained and coordinated product complaint system in a timely manner ensuring customer satisfaction. • Conducted formal management review of the quality system quarterly ensuring compliance with required regulatory bodies.• Developed improvements on existing processes to eliminate waste and reduce manufacturing lead times.

Morrisburg, On

• Maintained and administered cost effective calibration system for over four hundred measuring and test devices ensuring compliance and eliminating waste and reducing processing costs.• Administered, evaluated and controlled special test runs verifying test plans were clearly defined and documented thus ensuring valid and conclusive results and improved cost control.• Performed regularly scheduled internal quality system audits identifying opportunities for improvement and reducing costs.• Analyzed processes for compliance to applicable regulations and standards and resolved any discrepancies thus reducing costs and improving service levels.