Quality Assurance Leader
Other, Plaquemine, Louisiana, USA
Promotes a customer focused quality culture by acting as the plan subject matter expert in quality programs, processes and tools. Ensures the Quality Management System fulfills all quality assurance standards and requirements and it continually improving. Focal point for product stewardship. Enhances the front-line knowledge and accountability for quality and product stewardship.
Implements and maintains the business quality programs.
Handle product stewardship, product laws and regulations requirements, FCN and GMP.
Communicate at all levels within Quality as well as cross-functionally with departments such as Engineering, Manufacturing, Logistic and Product Management to drive continuous improvement.
Support maintenance of existing products including design changes, process changes and remediation and new product development through design verification and validation activities.
Maintains ISO-9001 certification and hold related quality meetings.
Investigates customer complaints and drives resolution through root cause analysis and implementation of corrective actions.
Reviews and revises metrics/measurements that monitor plan quality performance.
Identifies and leads improvement opportunities as determined through customer audits, 3rd party certification audit, TSRC audit and other quality-related programs.
Plans internal audits and conducts audits of the site facilities, including plants, labs and warehouses, suppliers, contractors and other central facilities and functions as applicable.
Plans quality education and training.
Handles customers request for product quality.
Maintains quality modulus of SAP.
Monitors IQC、in-process、OQC data and issues COA.
Executes document control through Ecesis.
Provides monthly quality performance and customer complaint status to TSRC-QA.
Works with business, RD and plant personnel to introduce new products.
Other duties that may be requested by TSM management.
Bachelor’s Degree required
• 5+ years previous Quality Assurance experience in engineering and manufacturing environments.
• Working knowledge of safety requirements, legal standards, and quality system requirements.
• A demonstrated knowledge of quality assurance and quality control, approaches & tools, including strategic planning and project management.
• Advanced leadership skills in team leading, goal setting, training, and achieving results.
• Excellent communication skills and interpersonal skills.
• Proactive, possessing initiative, driven with a ‘can-do’ attitude.
• Expect to travel 25% of the time including domestic and international travel. International travel may include the EU, Asia, and South America.
• This position also requires attending teleconferences with Asia to accommodate time zone difference.