Quality Assurance Director- Healthcare jobs in Kentucky

AAF International offers the most comprehensive clean air solutions available across the globe. Selling under the American Air Filter and the AAF International brand names, AAF International has been an industry pioneer since 1921 with manufacturing operations in 22 countries and over 6000 employees globally. Our products are the industry benchmarks for quality and performance. Our applications include commercial, industrial and residential solutions from the filters used in your home to the most critical cleanroom and power generation applications.

We are a member of the Daikin Group, the world's largest air conditioning provider with $30 billion in revenue and over 75,000 employees worldwide. Founded in 1924, Daikin has grown into a diversified industrial manufacturing company offering solutions in clean, air, air conditioning, refrigeration, chemicals, oil hydraulics, defense systems and electronics.

Our culture of continuous improvement, safety and world class operations is driven by our people-centered management philosophy. This philosophy is built around mutual selection: that while AAF seeks top talent people to join and deliver on our team, we also want each team member to receive job satisfaction, growth & development, and continued happiness in being a long-term member of the AAF family. This is fueled by our belief in treating our people, our supply partners, our customers and our environment with the trust and respect we each require, and our passion to give back to our community for our success.

Read more about our philosophy at: http://www.daikin.com/about/corporate/philosophy/index.html

AAF International is an Equal Opportunity Employer M/F/Disability/Veteran.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics.

Position Objective:

The Senior Director of Quality Assurance is responsible for leading AAF International's Quality Assurance efforts across all manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. This position also manages the Quality Assurance strategy of the organization to facilitate continuous production of products consistent with established industry standards, government regulations and customer requirements. The High Purity plant Quality Assurance Managers will report to this position.

Key Accountabilities:

• Deploy the Strategic Quality Plan for High Purity and provide overall quality leadership to the organization.
• Be tenacious in driving the continuous improvement efforts throughout the operation in support of Total Quality Leadership and the AAF International Quality Management System.
• Provide support in Total Quality Leadership to customers, suppliers, partners and the support service functions of the organization.
• Establish and maintain quality standards, policies, and procedures for all manufacturing processes, including incoming materials inspection, in-process quality control, and final product inspection.
• Collaborate with cross-functional teams, including manufacturing, engineering, procurement, and supply chain, to identify and address quality issues, root causes, and corrective actions.
• Drive continuous improvement efforts to optimize manufacturing processes, reduce defects, and enhance overall product quality and reliability.
• Partner with regulatory affairs to ensure compliance with relevant industry standards, regulations, and certifications, such as ISO, FDA, and other applicable requirements.
• Conduct regular audits and assessments of manufacturing facilities, suppliers, and vendors to ensure adherence to quality standards and specifications.
• Analyze quality data, trends, and metrics to identify areas for improvement and develop action plans to address deficiencies and drive performance improvement.
• Serve as a key point of contact for customer quality inquiries, concerns, and escalations, providing timely and effective responses and solutions to maintain customer satisfaction.
• Prepare and present quality reports, metrics, and performance updates to senior management and key stakeholders, highlighting achievements, challenges, and opportunities for improvement.

Position Requirements:

1. Bachelor's degree in engineering, quality management, or a related field; advanced degree preferred.
2. Minimum of 10 years of progressive experience in quality assurance roles within manufacturing environments, with at least 5 years in leadership positions.
3. Strong understanding of quality management principles, methodologies, and tools, such as Six Sigma, Lean Manufacturing, Statistical Process Control, etc.
4. Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives to achieve operational excellence and customer satisfaction.
5. Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.
6. Demonstrated ability to develop and implement strategic quality plans and initiatives to achieve business objectives and drive sustainable results.
7. Knowledge of relevant industry standards, regulations, and certifications, such as ISO 9001, ISO 13485, FDA QSR, etc.
8. Experience with quality management systems (QMS) implementation and maintenance, preferably in regulated manufacturing environments.
9. Strong analytical and problem-solving skills, with the ability to analyze complex data sets, identify trends, and develop actionable insights and recommendations.
10. Ability to thrive in a fast-paced, dynamic environment and effectively manage competing priorities and deadlines.
11. Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma Black Belt, etc.) is a plus.