U.S. Quality Director (26516)

Summary:

Oversees and directs Quality Assurance Activities and Functions within A&D Segment. Assures that Quality is built into our processes and culture, and that we are in compliance with all applicable NEOTech, Customer, Industry, Government, and third party Quality Standards and requirements. This role will report to the President of Aerospace & Defense, with direct accountability for multiple high-cost-of-failure design and manufacturing sites within North America.

Essential Duties and Responsibilities:

• Ensures that internal and external quality assurance procedures adequately evaluate products and processes, including submissions to regulatory authorities; develops and implements required modifications.
• Establishes and monitors vendor compliance program; develops and implements audits of external component/material vendors, contractors, collaborators, and other relevant organizations as needed.
• Oversees reporting on all vendor quality-related activities; assures that vendors adhere to quality requirements and that a quality system is maintained.
• Develops and manages ISO9001:2000, AS9100B, ISO 13485 and internal audits on products, stability programs, complaints, and related systems.
• Works with all federal and state regulatory agencies and customers on all internal audits.
• Documents audit observations and recommends, corrective actions as needed.
• Creates and maintains quality assurance databases, reports, and files; oversees preparation of audit reports.
• Coordinates with development, project management, and other appropriate departments to create systems that ensure integrity and quality of submitted data.
• Maintains current knowledge of government and industry compliance standards.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
• Collaborates with research and development during new product start-ups and product development; establishes key checkpoints for new products and processes.
• Identifies and investigates in-house quality issues.
• Develops and maintains auditing schedules and budgets.
• Hires, trains, supervises, motivates, develops quality assurance staff; manages schedules and workflow.
• Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and governmental regulations.
• Participates in customer QBR process and driving a positive customer experience.