Associate Director, Quality Process # 4648

Responsibilities:

• Develop and implement long-term quality system strategies, policies, and objectives aligned with organizational goals.
• Lead multiple quality teams, including engineers, technicians, and managers, providing direction, coaching, and career development.
• Oversee quality assurance and compliance programs to ensure adherence to internal standards, customer expectations, and regulatory requirements.
• Partner with senior leadership across the company to improve processes and enhance product quality.
• Lead organizational readiness for external audits, inspections, and customer assessments, serving as the senior quality representative.
• Analyze enterprise-level quality performance metrics, identify systemic risks, and implement strategic solutions.
• Drive continuous improvement initiatives across functions to enhance efficiency, reduce risk, and improve quality outcomes.
• Influence product development and lifecycle processes by embedding quality into design, validation, and manufacturing.
• Represent the organization with customers, regulatory agencies, and external partners on quality matters.
• These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Required Qualifications:

• Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field; Master's degree strongly preferred.
• 12+ years of experience in quality engineering, process engineering, or manufacturing, including 5+ years in a leadership or management role.
• Demonstrated success leading quality organizations through audits, regulatory inspections, and customer assessments.
• Strong knowledge of global quality management systems, regulatory compliance frameworks, and industry standards.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
• GMP quality management systems (e.g. ISO 13485)
• Risk assessment frameworks (e.g. ISO 14971)
• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
• Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Preferred Qualifications:

• Strategic leadership skills with the ability to align quality initiatives to business objectives.
• Expertise in advanced quality engineering tools and methodologies (FMEA, DOE, SPC, Six Sigma, Lean).
• Strong organizational change management and continuous improvement capabilities.
• Excellent communication and executive presentation skills, with experience influencing senior leadership.
• Proven ability to lead and develop high-performing teams across multiple levels.
• Financial and operational acumen to manage budgets, resources, and cross-functional priorities.

Physical Demands and Work Environment

• Work performed in office, production, and laboratory environments; frequent cross-functional engagement.
• Travel may be required to support audits, inspections, or collaboration with global teams and suppliers.
• Regular use of PPE in production and laboratory settings.
• Standard weekday schedule with flexibility for extended hours during regulatory inspections, customer visits, or critical investigations.