The Quality Manager is responsible for the quality systems and product quality at the manufacturing facility and distribution center. The position manages the Quality Control Lab, Production Quality, Quality Assurance and other related Quality functions required to ensure the Quality Management System is effective.  The person directs quality improvement programs at the plant working with the local plant management staff and implements Corporate Quality initiatives. 

The reporting structure is solid line to Corporate Global Quality to maintain Independence and dotted line to Plant Management.  Critical Success Drivers are developed in combination with both Corporate and Plant objectives.  On site Plant Management is responsible for day to day activities.  All communication is to Plant Management first, then Corporate as required. 

Role Accountabilities and Responsibilities  

• Provides Quality Leadership to support plant quality with focus on the production of Quality Product, Continuous Improvement, compliance to Good Manufacturing Practices and Regulatory/Legal requirements. Develop programs to ensure manufacturing systems are in control and capable of meeting defined specifications.
• Communicate plant quality issues to Plant Management and Corporate as appropriate.
• Implement Corporate Quality Initiatives.
• Manage Quality Budget within the guidelines and direction of Plant Management.
• Ensure the Quality Group is trained and staffed with competent personnel.
• Coordinate third party and internal quality system audits to document compliance to Regulations. 
• Ensure compliance to Regulatory and Legal Requirements.
• Interact with Corporate Brand Teams and R&D Groups on new products and product improvements, coordinating R&D test trials.
• Apply Lean Six Sigma processes to achieve cost savings targets for the plant.
• Ensure B2B customer complaints are investigated and closed out.
• Develop and maintain Key Quality Performance Indicators.

Education & Experience

• BS/MS degree from an accredited institution in Science related field
• Minimum 8-10 years’ experience in the consumer products, food mfg., medical device, and/or pharmaceutical industries
• Experience working in a plant environment
• Knowledge of quality management systems, cGMP and Regulatory Requirements

Skills & Competencies

• Excellent influence and persuasive skills
• Demonstrated leadership with significant results achievement
• Able to embrace new ideas
• Knowledge of Regulatory Requirements for 21 CFR 110, 111, 117 and 210/211