Quality Manager - Regional

• Establish, implement, and maintain quality systems in accordance with the International Standard AS9100, ISO 13485 and ISO 9001 specification.
• Ensure compliance with industry-specific regulations and standards, including ISO standards for aerospace, defense, and medical devices.
• Administer the compliance of First Article Inspection (FAI) and/or Production Part Approval Process (PPAP) requirements.
• Develop, maintain, and control quality records, ensuring traceability and adherence to established procedures.
• Coordinate customer quality audits of the company's quality systems, ensuring thorough preparation and successful outcomes.
• Lead internal quality audits, providing support for corrective action implementation and follow-up.
• Coordinate annual improvements to the quality system, including the review and update of procedures and the application of APQP principles.
• Participate in supplier quality audits, ensuring suppliers comply with ISO and AS9100 standards, and maintain records of supplier performance.
• Identify and coordinate annual quality-related training programs for the organization.
• Assist in the development and distribution of control plans to ensure consistent quality standards across all processes.
• Establish and maintain procedures for incoming material inspection, product traceability, and monitoring and control of special processes.
• Monitor quality performance according to established procedures, identifying, evaluating, and coordinating the implementation of improvements in products and processes.
• Ensure that quality data is accumulated, evaluated, and communicated to relevant personnel for necessary action.
• Develop and maintain procedures for managing non-conforming products and track progress to establish improvement plans.
• Establish procedures for inspection and testing activities, ensuring accurate documentation and maintenance of records for inspecting, measuring, and testing equipment.
• Communicate corrective action plans to customers and oversee their implementation to address any identified quality issues.
• Manage ITAR (International Traffic in Arms Regulations) compliance, ensuring that all processes, documentation, and records meet regulatory requirements for handling defense-related materials and information.
• Develop and implement training programs to ensure employees understand and adhere to ITAR regulations and guidelines.
• Coordinate with cross-functional teams to ensure export control compliance and resolve any ITAR-related issues promptly and effectively.
• Monitor changes to ITAR regulations and update company policies and procedures as needed to maintain compliance.

• Extensive knowledge of quality systems, particularly in aerospace, defense, and medical device sectors.
• Proven experience with AS9100, ISO standards, and the application of APQP.
• Ability to manage compliance with FAI, PPAP requirements, and other industry-specific regulations.
• Demonstrated expertise in managing ITAR compliance, including export controls and defense-related quality standards.
• Strong leadership skills with the ability to coordinate and lead quality audits, both internal and external.
• Demonstrated ability to drive continuous improvement initiatives and implement effective corrective actions.
• Expertise in developing and maintaining quality procedures that ensure compliance and enhance overall product quality.
• Proficient in data analysis and statistical techniques to monitor quality performance and identify areas for improvement.
• Ability to develop and execute corrective action plans that effectively address quality issues and prevent recurrence.
• Strong communication skills with the ability to convey quality-related information clearly and effectively to all levels of the organization and external stakeholders.

• Bachelor's degree in engineering, quality management, or a related field or 5 years related experience.
• Minimum of 5-10 years of experience in quality management, with significant exposure to aerospace, defense, and medical device industries.
• In-depth knowledge of AS9100, ISO standards, APQP, FAI, PPAP, and other relevant quality management systems.
• Experience managing ITAR compliance, including understanding and application of export control laws.
• Certified Quality Engineer (CQE) or similar professional certifications are highly desirable.
• Strong project management skills and experience in leading cross-functional teams.

• Competitive salary and performance-based bonuses.
• Comprehensive benefits package, including health, dental, and vision insurance.
• Opportunities for professional growth and development.
• Collaborative and supportive work environment.

Sko-Die