Quality Systems Specialist

POSITION TITLE: Quality Systems Specialist 

POSITION SUMMARY 

The Quality Specialist is a key position within Comar Quality organization supporting various quality management system processes, particularly document control and change control. The individual in this role will act as change control champion and ensure that change control requests move through the system efficiently. They will also own the document control processes for control and management of QMS documents throughout their lifecycle in compliance with Comar’s QMS. Individual in this role will support QMS activities at plant / corporate level related data analytics and reporting and will work closely with key stakeholders in maintaining compliance programs to ensure sustained conformance to published standards. 

ESENTIAL DUTIES and RESPONSIBILITIES 

• Support various functions for Change control requests from initiation through completion. 
• Assist in scheduling, facilitating and reporting on Change Control Board meetings. 
• Manage the Quality Document Control process. Assign document numbers, support creation of various corporate quality documents and their review, approval, training and implementation. 
• Own and maintain the Quality Management document libraries for ISO and SQF. Catalog and organize QMS related controlled document files within the Document Management System for storage, easy access, and retrieval. 
• Coach, guide and assist the team for compliance and effective use of Change Control and Document Control processes. 
• Assist in collecting, analyzing, and reporting on various Quality Management System related metrics and support effort to improve various metrics. 
• Assist in ensuring Quality training content stays aligned with approved and released QMS documents.  
• Support internal and external audits and regulatory inspections, as necessary.  
• Partner with Corporate Quality team and the key stakeholders to improve the Change Control, Document Control and other QMS processes. 
• Support Quality Management System and Compliance group for driving education and engagement of employees in improving practice of Quality within the organization. 
• Assist in complaint handling, maintaining customer complaint documentation, while initiating non-conformance reports and actively assisting with root cause determination and implementation of Corrective and Preventive Actions. 
• Maintain key elements of the plant's Compliance Programs by leading efforts to ensure conformance to ISO and Food Safety Standards, and actively participating in third party audits. 
• Provide Customers with prompt responses to requests for Compliance and/or Product Stewardship documentation. 
• Adhere to all applicable ISO, Safety, Food Safety & Quality standards; Complete training as required. 
• For SQF certified sites, this role also might be identified as a SQF Practitioner and HACCP team member, contributing to ongoing identification of hazards due to any change or New Product Introduction and support the HACCP team in implementation of the proposed Risk Mitigation plan.  
• Additional duties and tasks as assigned by management. 

KNOWLEDGE, SKILLS, and ABILITIES 

• Knowledge of typical Quality Management System elements in a regulated industry 
• Excellent written and verbal communication skills are required 
• Must have strong ability to read, analyze, and interpret general company policies and departmental procedures. 
• Must be able to effectively communicate with all levels of management and production employees, as well as customers and sales representatives. 
• Ability to work effectively in both a team and individual setting, while demonstrating good organizational and time management skills. 
• Possesses a sincere commitment to business ethics and integrity, as well as self-motivation and initiative. 
• Must be able to observe all company policies, and safety rules and regulations.   
• Strong computer skills with MS Office, Visio, Smartsheet and with ERP systems such as iQMS or SAP 
• Experience with Business Process Improvements preferred 
• Understanding of principles and practices of Project Management preferred 
• Experience with quality testing procedures, measuring equipment, & calibration practices preferred 
• Honesty, integrity, and a clear sense of ethical decision making 
• Ability to work collaboratively across various levels in the organization 
• Ability to prioritize multiple tasks and demands and to create sense of urgency for the fast-paced manufacturing environment 
• Inquisitive, self-starter and can work autonomously with minimal supervision 
• Strong organization & time management skills 
• Strong customer focus 

Education & Experience 

• Bachelor’s degree with 3 years of experience or Associate degree with 7 years of experience in manufacturing environment  
• Minimum of 3 years of experience working with critical Quality management systems such as document control, change control, complaint handling, non-conformance  processes 

Physical Demands 

• Stand and walk for most of the work shift 
• Use hands and fingers to handle or feel; reach with hands and arms; crouch, bend, kneel and only occasionally sit 
• Lift and/or move up to 25 pounds. Assistance is available 
• Use close, color and peripheral vision, depth perception, and adjust focus 

Working Conditions 

Frequently exposed to moving mechanical parts.  The noise level in the work environment is usually loud and requires the use of hearing protection.