As a Quality Specialist II, you will play a pivotal role in ensuring the highest standards of quality and compliance across our organization. You will work closely with cross-functional teams to investigate customer complaints and quality issues. Your attention to detail, analytical skills, and ability to collaborate effectively will be essential in driving continuous improvement and maintaining regulatory compliance.

• Quality Investigations: Lead and conduct thorough investigations into quality issues, deviations, and customer complaints through root cause analysis and corrective and preventive actions (CAPAs). Monitor the effectiveness of CAPAs to prevent recurrence.
• Quality Management Systems: Implement, maintain, and improve quality management systems (QMS) in accordance with regulatory requirements and industry standards.
• Process Improvement: Identify opportunities for process optimization and efficiency gains within processes. Develop and implement solutions to enhance overall quality performance.
• Quality Assurance: Conduct audits and assessments to ensure compliance with internal quality standards, regulatory requirements, and customer specifications. Develop audit plans, conduct audits, and report findings to management.
• Document Control: Assist in the creation, review, approval, and control of quality documents, including standard operating procedures (SOPs), work instructions, and quality records.
• Training and Development: Develop and deliver training programs on quality management processes, procedures, and best practices. Ensure that all personnel are adequately trained to perform their quality-related duties.
• Quality Metrics and Reporting: Establish key performance indicators (KPIs) and metrics to monitor and evaluate the effectiveness of quality management systems. Prepare regular reports for management review.
• Cross-Functional Collaboration: Work closely with other departments, including manufacturing, engineering, maintenance, and warehousing, to address quality-related issues and drive continuous improvement initiatives.
• Bachelor's Degree or equivalent experience
• Technical writing experience preferred
• 2 to 4 years previous experience in a manufacturing environment preferred
• Strong knowledge of quality tools and methodologies, such as root cause analysis, risk management, and statistical techniques.
• Excellent communication, interpersonal, and problem-solving skills.
• Ability to work effectively in a fast-paced environment and manage multiple priorities simultaneously.
• Strong attention to detail
• Strong problem-solving skills
• Sound time management and prioritization skills
• Ability to work well with various departments in the company
• Proficient with Microsoft Office programs (Word, Excel, and PowerPoint)
• Self-starter