Develop and maintain a Quality Management System that meets and complies with all the requirements of ISO 9001 Quality System.
Develop and manage plans, guidelines, policies, and processes, to ensure the achievement of quality targets.
Create and develop the program life cycle process for the commercialization of Sakuu products
Accountable for the successful launch and documentation of new products
Facilitate core team meetings and design reviews, take minutes, and follow up on routine action items with assigned owners. Update stakeholders on the status and drive the communication plan to execution.
Prepare Sakuu for ISO 9001 certification audit, and coordinate 3rd party product testing for safety and transportation of Sakuu products. (UL 1642 and UN38.3)
Control and manage the Document Management SystemManage the activities of the technical documentation function including engineering/manufacturing SOP documentation, drawings, Bills of Materials, parts list, specifications, and engineering change orders.
Review change order submissions for completeness, accuracy, and reference compliance, and process accordingly. Ensure that existing Change Order procedures and Documentation Standards are followed and adhered to.
Establish and manage proper document review processes
Establish RMA (Customer Returns) logging, tracking, and weekly status reporting.
Release new, change existing, obsolete old, and distribute soft copies of controlled documents to Suppliers and CMsEnsure that all products and processes are compliant with internal and regulatory standards
Contribute to the building of a world-class supply base through the implementation of a robust Supplier Quality Management program.
Prepare the site for Customer and Auditors' Quality AuditsHire and manage Document Control Associates
Provide a weekly summary of decisions, issues, and actions, and ensure Executive Staff is appropriately informed and can act accordingly
Requirements:
Bachelor's degree and 10+ years of prior relevant Quality Assurance / Quality Control leadership experience
The ability to define, document, analyze, trace, prioritize, and confirm requirements throughout the entire program life cycle.5+ years of program management experience
Extensive experience with ISO 9001:2015 process and certification activities
Broad and deep experience in product development, industrialization, and production of high-volume products
Excellent verbal, written, and listening communication skills
Excellent analytical, problem-solving, negotiation, and organizational skills.
Proactive and collaborative approach to problem-solving with a vision for how product and process creation can move forward
Ability to thrive within a matrix organization with a Flexible/adaptable / dynamic / "can-do" attitude
