Quality Manager (Medical / PCBA / HLA)

Overview

Purpose Statement :

The Manager of Quality supports the strategic planning, development, execution and compliance of Plexus’ corporate Quality Management System (QMS) to all applicable quality regulations and standards. To differentiate Plexus from the competition, the Manager of Quality supports and helps creates a culture of quality and helps builds customer confidence by leading Plexus’ quality, supplier and regulatory teams (as applicable) and collaborating across the enterprise in order to ensure Plexus delivers defect free designs and products. Responsibilities

Quality Management Representative :

Leads overall Quality function as QMS Management Representative for the site, inclusive of; Quality Engineering, Regulatory Compliance (as applicable to the QMS), and Supplier Quality. Quality Performance :

Leads monitoring and maintenance of site Quality Metrics in order to identify and deploy best practices and drive continuous improvement. In addition, help develop and upgrade Quality site talent to ensure success. Continuous Improvement :

Drive the use of problem solving tools and methodologies consistent with the lean sigma Plexus culture. Accountable to drive and lead the CAPA performance and execution within the region. Lead the operational quality assurance, supplier quality and QMS / regulatory teams to establish a quality roadmap for the continual improvement of manufacturing operations and supply base to improve quality, cost and delivery of customer products. Audits :

Manage external / internal site audit processes and associated improvement cycle. Core Values & Leadership :

Responsible to exemplify and hold their team accountable to demonstrating the Plexus Core Values. Leader will focus on evaluating potential, driving succession planning, and ensuring their employees receive the development and coaching required to realize their full potential. Qualifications

Education / Experience Qualifications :

Bachelor’s degree and a minimum of 8 years of experience in the related field. May require previous supervisory experience. A combination of education, experience, and time in field will be taken into consideration, and internal candidates may have distinct requirements tailored to their demonstrated skills and contributions within the organization. Other Qualifications :

Displays Plexus Core Values as applicable. Advanced knowledge and implementation experience in applicable QMS standards and regulations (i.e. ISO 9001, AS9100, FDA QSR, TL9000, etc.). Advanced knowledge in applicable industry standards (IPC, J-STD, etc.). Capability to assess, manage, develop, and mentor Quality organization personnel. Knowledgeable in Lean and Six Sigma concepts and tools. Expert communication and presentation skills. Knowledgeable in data analysis tools. Strong cross-functional team building skills. Ability to lead and multi-task in a dynamic environment. Ability to quantify and assess benefits / risks of process improvements. Note :

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