Director – Quality Management – EMI Operations – Sustaining and Service

Director – Quality Management – EMI Operations – Sustaining and Service

Requirements

• Bachelor’s degree in a technical field required
• Engineering degree strongly preferred
• Master’s degree in a technical field preferred
• Minimum of ten (10) years’ experience in Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSR’s (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements
• Knowledge and application of ISO 13485, 21 CFR 820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture
• Experienced in project management
• Organizational / motivational skills
• Capable of managing a range of projects and activities in parallel
• The ability to manage by influence in addition to functional responsibility
• The preparation, planning and presentation of key initiatives
• The ability to coordinate effectively across regions

Responsibilities

• Provide input into and support the VP Quality EMI in the development of the overall EMI plant and sustaining quality strategy
• Develop quality programs to oversee and foster process capability, new products supplied component readiness and introduction, product enhancements, material changes, operations quality and supplier quality expert-level leadership and guidance for a dedicated team
• Manage the EMI product lines’ manufacturing and depot repair quality practices
• Serve as the primary liaison between quality and platform leadership
• Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and developing them
• Develop, deploy, and maintain a robust and compliant quality management system for the design, risk management, and ongoing life-cycle maintenance of BD products
• Actively identify improvements to the processes within the QMS to enhance both compliance and quality
• Provide expert-level understanding of qualification and validation, nonconformance control, process capability, risk reduction, and supplier management requirements and how to deploy them in a large-scale and rapidly evolving business
• Provide operations and supplier quality leadership during FDA and notified body site inspections
• Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information requests
• Acquire and develop excellent-level leaders and teams to support the EMI mission and actively manage bench-strength and succession planning
• Assess resource needs to align the required level of quality support provided when needed with suitable competencies, including shifting resources between Platforms when appropriate
• Maintain effective design-related quality metrics and define and execute activities to improve performance
• Actively support and demonstrate the BD values in daily work
• Other assignments as directed by the Vice President Quality Management EMI

Preferred Qualifications

No preferred qualifications provided.