Quality Director Jobs

About The Position

Requirements

• Bachelor’s degree in a related field of study.
• At least 12 years of related professional experience in quality, R&D, and/or manufacturing.
• At least 5 years of management or leadership experience.
• Extensive medical device industry experience and business knowledge, with comprehensive understanding of the organization and functional area.
• Excellent command of FDA and ISO medical device quality system requirements.
• Excellent knowledge of medical product manufacturing, process validation, test method validation, and risk management.
• Excellent ability to provide technical leadership in evaluating product quality issues.
• Excellent verbal and written communication and interpersonal skills.
• Excellent negotiating and influencing skills.
• Proficiency with MS Office Suite, SAP, and statistical software; Minitab is preferred.
• Ability to work onsite five days a week.

Nice To Haves

• Master’s degree in a related field of study.
• Ability to understand the technology related to MicroVention’s products.
• Experience with software used to manage quality information.
• Experience with the auditing process.

Responsibilities

• Develop and implement strategies to enhance product quality and compliance in collaboration with senior quality management.
• Develop guidelines and complex processes and procedures for quality engineering groups.
• Manage managers, engineers, and technicians supporting medical device manufacturing.
• Manage quality managers and engineers working with Manufacturing Engineering and R&D to review process changes and resolve quality issues.
• Oversee quality engineers investigating corrective actions associated with nonconforming product and customer complaints.
• Manage quality engineers leading quality management system improvements, remediation projects, and cost reduction opportunities.
• Execute product holds in the system to prevent inadvertent release of nonconforming goods.
• Coordinate and execute Engineering Order, Quality Plan, and Quality Improvement Project activities to support business needs, corporate strategies, and Global Quality objectives.
• Communicate and collaborate with other departments to achieve Quality Engineering and company goals.
• Resolve critical issues and contribute to organizational development.
• Define team functional goals and objectives and monitor performance throughout the year.
• Make strategic decisions based on company goals and objectives.
• Support internal and external inspections as a subject matter expert in the front room.
• Control functional budgets and expenses and allocate resources.
• Escalate quality and compliance issues to senior quality management and propose and work on effective solutions.
• Contribute to ERP workflow design and improvements for product holds, traceability, and materials management.
• Comply with applicable laws and regulations and Quality Management System requirements, and demonstrate ethics and integrity.
• Perform additional duties as assigned.
• Own the product non-conformance procedure, ensuring timely execution and closure, actions and corrections, material disposition, process performance monitoring, and KPI reporting to Quality Leadership.
• Collaborate with Manufacturing, R&D, Regulatory, and other Quality areas on process changes and transfers, product design improvements and transfers, new product implementation, and quality management system compliance.