About This Role
Leading the organization's quality management initiatives across all manufacturing and production operations is the core of this pivotal role. You will champion the development, implementation, and continuous improvement of quality systems, ensuring compliance with industry standards, regulatory requirements, and customer expectations. This role suits a visionary professional passionate about elevating quality assurance and control to new heights.
Responsibilities
- Develop and oversee comprehensive quality management systems aligned with industry standards such as ISO 9001, ISO 13485, GMP, HACCP, CGMP, and Lean management principles
- Lead internal and external quality audits to ensure compliance with regulatory frameworks including FDA regulations and legal standards governing manufacturing practices
- Establish rigorous quality control procedures for production processes, including quality inspections, analysis skills assessments, and GD&T (Geometric Dimensioning & Tolerancing) practices
- Drive continuous improvement initiatives utilizing Six Sigma manufacturing methodologies to optimize efficiency, reduce defects, and enhance product reliability
- Manage cross-functional teams involved in quality assurance (QA), quality control (QC), regulatory compliance, and manufacturing operations to foster a unified approach to quality excellence
- Monitor and analyze key performance indicators related to product quality, process efficiency, and compliance metrics; implement corrective actions as needed
- Ensure all products meet stringent quality standards while adhering to regulatory/legal compliance standards in production environments
Requirements
- Proven track record in practicing within an industrial or manufacturing engineering role with extensive experience leading quality assurance teams in complex production settings
- Deep knowledge of ISO 9001, ISO 13485 (medical devices), GMP (Good Manufacturing Practices), HACCP (Hazard Analysis Critical Control Point), CGMP regulations, and FDA compliance standards
- Demonstrated expertise in conducting thorough quality audits and implementing robust quality systems across multiple sites or facilities
- Strong leadership skills with experience managing cross-functional teams in high-pressure environments; ability to communicate effectively across departments
- Expertise in applying Six Sigma principles and lean management techniques to streamline processes and eliminate waste
- Analytical skills capable of interpreting data trends to inform strategic decisions for process improvements and risk mitigation
Benefits
- 401(k)
- Dental insurance
- Paid time off
- Vision insurance
Important Details