Quality Manager at Clayens NP USA, INC – Crystal Lake, Illinois

Essential Job Functions:

• Develop, implement, and maintain the Company's Quality Management System.
• Represent Company's Quality Management system during third party registration surveys.
• Maintain the internal quality audit program and to report on the performance of the system to the Management Review as an ongoing basis for improvement.
• Provide technical support to company operations, and manage the Quality Department activities, including employee training and performance.
• External customer liaison providing required documentation for new product development, supplier quality problems/resolutions and corrective actions.
• Maintain general quality department compliance to developed procedures and requirements.
• Participate in MRB and approve all internal Inspection Rejection reports for corrective action effectiveness at completion and distribute results to management team.
• Acts as the local ISO Management Representative per Clayens Crystal Lake Quality Management System (QMS)
• Adheres to safety policies and strives to maintain our outstanding safety record.
• Keeps work area, tools, supplies and equipment clean and organized.

Other Job Functions:

• Performs other job-related and department-related duties as assigned.

Supervisory Responsibility:

• Plan, organize, analyze, and implement all quality improvements and initiatives.
• Communicate and Implement appropriate Corrective Actions for any negative observations or areas of improvements during third party registration audits.
• Provide and implement effective corrective actions to resolve customer / supplier issues.
• Issue required and approved appropriate corrective action to suppliers.
• Staff, procure, and maintain required Quality Assurance department resources.

Experience, Knowledge, Skills and Abilities required:

• Education: Bachelor's degree in a related field (Engineering, Quality, Business Management)
• 5+ years experience in an ISO/FDA quality system environment
• Formal quality certifications
• Extensive experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 13485) or 21 CFR 820 within a regulated industry
• Advanced Microsoft Word and Excel, PowerPoint, Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
• Combinations of education, training, and experience to successfully accomplish responsibilities.
• Extensive knowledge of compliance and processes.
• Strong self-motivation, the ability to work independently and within a team environment. Ability to work with others in a positive and collaborative manner.
• Must have excellent attendance record.
• Ability to work safely and with minimal supervision
• Ability to clearly communicate and interact with all levels of personnel professionally
• Ability to follow written and verbal directions and complete work independently
• Ability to adhere to workplace rules
• Excellent attention to detail.

Work Environment/Physical Requirements:

• Ability to stand for long periods of time.
• Standing, walking, bending, reaching, kneeling.
• Possibility of exposure to noise, uncontrolled temperatures, and chemicals.