Position Summary: The Quality Management System Manager (QMSM) will oversee and is responsible for the Quality Management System (QMS). The QMSM is responsible for developing our quality strategy, policies, processes, standards, and systems for the Company and its supply chain. The QMSM will sustain the Quality Management System to maintain ISO 9001:2015 certification. Essential Duties and Responsibilities: Develop, implement, manage, and maintain continual improvement of QMS programs, policies, and procedures. Write, review, approve, and implement quality procedures, specifications, processes, and methods as required. Ensure compliance with all applicable standard operating procedures and regulations. Review documents associated with the site's QMS program for completeness, errors, and omissions. Apply quality assurance processes and procedures to ensure quality and compliance. Ensure that all in-house systems and procedures are updated, revised, and modified to meet the needs of external certification bodies. Ensure compliance via auditing although this may be carried out by a third-party accredited body. Strong collaboration, including problem solving and continuous improvement efforts, and communication with Leadership. Assist with development of department objectives, metrics and KPI's. Prepare and present periodic review of the quality system, including performance metrics and KPI's as related to the QMS, for regular Management Review meetings. Ensure that all staff members are properly trained and qualified, and that training tracking and documentation is accurate and maintained in a timely manner. Conduct periodic self-audits to monitor compliance with established procedures and practices. Liaise with internal and external inspectors and representatives, particularly on QMS-related topics. Development, review, and approval of facility, process, and equipment validations. Ensure equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify management problems in personnel, equipment, and the facility that require correction. Initiate corrective and preventive actions as necessary for continuous process improvement. Ensure any deviations from normal procedures are documented and justified. Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken. Attend quality and operational meetings with Operations on quality-related issues. Conduct risk assessments of processes and tasks in the department. Manage, coach, and develop a Quality Management team that meets agreed objectives, delivers best practice results, and contributes to continuous improvements. Provide status updates as required management. Any other duties needed to drive our Vision, fulfill our Mission, and abide by our Values. Job Qualifications/Requirements: Bachelor's Degree in relevant field of study with 4 + years' experience managing a QMS, or, if no degree is held, 8 years' experience managing a QMS. 3 years' experience managing a team. Experience with and full knowledge of ISO 9001:2015 requirements. Ability to write, review, and revise reports, business correspondence, and procedure manuals Standard Operating Procedure (SOPs). Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, inspectors, and auditors required. Ability to define problems, collect data, establish facts, and draw valid conclusions. Proficient in MS Office applications. Strong interpersonal communication skills. Advanced ability to effectively lead one or more projects with competing, while being adaptable to quickly changing priorities. In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Ability to foster an inclusive and cooperative work environment.
