Manager - Quality Management Systems

Position

The Manager - Quality Management Systems will be responsible for Process Quality Assurance by setting standards and discipline for corporate quality programs through operational excellence, competency building, strategy, and innovation. This will include assessing standardized and auditable means of maintaining a high-quality culture. The Manager will establish an effective Product and Client Quality Assurance program to support our clients globally. They will drive continuous quality improvement projects, global harmonization initiatives, and support global Industrial initiatives. In addition, this role will provide successful cross functional leadership, develop, implement and evaluate the Quality resources of the Quality Assurance and Quality Control (QA/QC), and customer quality strategies in alignment with the Corporate’s business strategy, the Supply Chain’s business objectives, the Global Quality’s direction, and the capacity.

Key Accountabilities

• Assess operational excellence and competency and identify actions to close the gaps.
• Own the product quality assurance metrics and the quality data.
• Utilizing the quality data, identify product improvement solutions, recommend potential modification in design, manufacturing process or test methods to meet requirements and to eliminate product issues proactively.
• Establish, update, maintain, and enforce quality assurance procedures and methods to comply with applicable industry requirements, regulatory requirements, and customer expectations.
• Identify risks of failure in the system, evaluate and create policies to reduce those risks in the effort to improve sustainable quality.
• Collaborate with the Product Regulatory and Compliance team to ensure compliance to applicable regulations in Quality policies and procedures.
• Responsible for data analysis of the quality performance trends and driving continuous quality improvement projects. Use data to drive improvement through disciplined metrics.
• Ensure effective management of Product and Client Quality Management processes including assuring effective management reviews, client quality issue management, CAPA system, change control, design quality and product quality support to the retails.
• Develop and implement processes and tools such as Quality Risk Management (QRM), supplier assessment/audit, and deviation trend management.
• Assure proper use of change management associated with validated processes.
• Recommend continuous quality improvement projects and global harmonization initiatives.
• Provide cross functional Leadership, develop, implement and evaluate Process Quality Assurance resource (QA and QC) and operational strategies in alignment with the corporate’s business strategy, the Supply Chain’s business objectives, the Global Quality’s direction, and capacity.