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Quality Manager
2 months ago
This role is responsible for leading a team focused on inspection and quality control procedures related to purchased materials, in-process materials, and finished products to ensure compliance with quality standards. The individual will oversee workers involved in measuring and testing products, as well as compiling and analyzing data concerning material, product, or process quality and reliability.
Key Responsibilities:
- Leadership and Oversight: Direct and manage employees involved in inspection and quality control for materials and products. Ensure that quality control standards are consistently met.
- Quality Programs: Oversee Quality programs and procedures across multiple facilities, including the Greendale Facility. Travel as required to support objectives.
- Work Planning: Plan and assign tasks to subordinates, develop and adapt inspection equipment, and suggest improvements to procedures, standards, and equipment.
- Equipment and Testing: Establish programs to evaluate the precision and accuracy of production and testing equipment. Maintain and improve testing, measurement, and analytical facilities.
- Problem Solving: Analyze problems or incidents of nonconformance, determine corrective actions, and apply root cause analysis.
- Documentation: Compile and maintain inspection reports and records. Investigate causes of faulty work and advise production supervisors on corrective measures.
- Standards Development: Develop and implement standards and methods for inspection, testing, and evaluation. Create procedures for material disposition and cost assessment.
- Work Improvement: Analyze and resolve work issues, assist workers with problem-solving, and suggest changes to improve safety and efficiency.
- Customer Complaints: Investigate customer complaints, conduct on-site evaluations, implement corrective actions, and communicate with relevant company departments.
- Regulatory Compliance: Maintain cGMP standards in compliance with regulations such as FDA, SFSF, etc., and prepare for and lead audits by customers and regulatory bodies.
- Additional Duties: Perform other duties as assigned.
Travel Requirements:
- 20%-30% travel may be required.
Education and Experience:
- Education: Bachelor’s degree in a technical field preferred.
- Experience: 5-10 years of experience in Quality Assurance or a related field, with a proven track record as a Quality Assurance Manager in technology-driven, developing companies.
- Regulatory Knowledge: Experience with FDA, OSHA, and International Quality System regulations is crucial.
- Skills: Strong oral and written communication, interpersonal skills, and organizational abilities. Initiative, confidentiality, ability to meet deadlines, and teamwork skills are essential.
- Technical Proficiency: Proficiency in PC-based software (Word, Excel, PowerPoint, and database/documentation software) is required.