Summary: The Quality & Regulatory Manager is responsible for all quality assurance related functions to include audits, sample collection, data analysis and testing as well as regulatory compliance. Defines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
Essential Duties and Responsibilities include the following (Other duties may be assigned):
- Drive all Quality Assurance activities and initiatives to ensure company goals and objectives are met.
- Participate in product improvement and implementation strategies.
- Continuously improving product quality, productivity, process efficiency, and customer satisfaction.
- Drive Preventative Action activities between Manufacturing, Engineering and Supply Chain for all products and processes.
- Responsible for incoming material quality.
- Define and monitor process equipment calibration.
- Administer internal and external audits.Establish and review maintenance and calibration of laboratory QC equipment, scales and balance and measuring devices.
- Establish and maintain good documentation practices for manufacturing and QA/QC
- Train QC/QA personnel and manufacturing personnel to carry out good documentation, good manufacturing practices and QC testing.
- Develop new and appropriate QC testing and inspection as needed to support new materials, products and end uses.
- Investigate quality complaints or internal quality reviews and develop corrective actions to address issues.
- Ensure compliance with regulatory agencies as appropriate.
- Author and review SDSs.
- Review requirements and/or provide documentation for EPA, DOT, REACH/ECHA or other regulatory agencies.
- Coordinate IMDS and CAS material submissions and similar industry specific registries.
- Demonstrate commitment to IFC Core Purpose and Values by leading, acting and behaving in a way consistent with these values.
- Follow all company safety policies and procedures to include attending all related safety training.
Essential Education, Skills and Experience:
- Bachelor’s degree in Science, Engineering, or related discipline required with 5 years of experience.
- Master’s degree or Ph.D. preferred.
- Professional certification (ASQ CQA, CQE) preferred.
- Knowledge of current good manufacturing practices, statistical process control and six sigma preferred.
- Product and process quality improvement experience.
- Strong working knowledge of Quality Management Control Systems and report generation.
- Strong cross department communication and negotiation skills.
- Process oriented and results driven with strong planning and execution skills.
- Proficient in Microsoft Office suite applications and tools.
- Manage, develop and coach a team of Quality professionals.
- Provide daily work direction to the organization, communicate company expectation metrics, and manage performance and improvement activities.
- Set cross-functional standards to ensure that the company’s internal and external customers are satisfied.