Quality Systems Manager

Summary Establish and maintain a configuration management system capable of meeting regulatory, quality, customer and company requirements for processing documentation in a manufacturing environment. Leads company initiatives, maintains policies and procedures and provides training for employees.

Key Accountabilities

• Actively promote and drive a culture of safety.
• Manage and maintain the Document Control function for prompt and accurate processing and the distribution of customer and internal documentation through the ECO and RDF process.
• Manage and maintain the SOP Employee Training Data Base providing the training documents required for ISO compliance and ensuring timely employee training required.
• Create and maintain the Bills of Materials providing accuracy and consistency throughout all SPG MN Operations.

Key Responsibilities

• Promote a safe work environment.
• Lead by example in support of a culture of mutual respect, honesty, communication, and teamwork.
• Provide continuous feedback to subordinates and co-workers.
• Assist Quality Manager in maintaining a configuration management system compliant with regulatory, quality, company, and customer (both internal and external) requirements.
• Maintain ERP system to manage documentation to ensure full compliance with regulations.
• Provides guidance and advice on methods, procedures, standardization and requirements.
• Responsible for controlling document new and change control through the ECO ERP system. Regulates the change process so that only approved and validated changes are incorporated into released product documentation.
• Collaborate with departments to ensure timely implementation of change requests.
• Ensures accuracy by reviewing release documents for completeness, authorization and system updates.
• Participate in ERP software validation activities.
• Develop new and maintain existing Bills of Materials (BOMs) for all items, to support the manufacture of customer orders.
• Support audits (internal, customer, ISO) in order to verify that regulatory and quality requirements have been met.
• Manage the Standard Operating Procedures (SOP) documentation system.
• Participate in creating, editing and final approval and processing of the Master SOP documents.
• Ensure compliance with controlled document format and content.
• Assist Teams in the review of Customer Terms and Conditions for requirements.
• Review and identify customer specification changes and provide the results to Engineering to determine their impact.
• Participate in engineering project kickoff meeting.
• Reconcile month end tooling sales for accuracy and approval to close project.