Quality Systems Manager

Join to apply for the Quality Systems Manager role at Spectrum Plastics Group, A DuPont Business
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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.

• Actively promote and drive a culture of safety.
• Manage and maintain the Document Control function for prompt and accurate processing and 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.

• 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.
• Process customer and government audit requests for audits of proper identification and complete documentation and asset verification for tools, fixtures, and gauges.
• Assist in processing customer requests for tool removal.
• Participate in Customer Production Contract or Purchase Order reviews for compliance.
• Assist in the preparation and review process for customer pricing contracts.
• Develop a centralized filing system for both hard copy and electronic documentation.
• Support teams as required.

A minimum 5 years work experience in a document management role. Must possess a working knowledge of document control processes. Proficient in Microsoft Office applications (Word, Excel, etc.) is required. Background knowledge in an ERP system (preferably IQMS is a plus). Excellent written and oral communication skills and a strong attention to detail are required. Strong organizational skills are desired. While performing the duties of this job, the employee is regularly required to sit.

The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls and talk or hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.

• Mid-Senior level
• Full-time
• Quality Assurance
• Medical Equipment Manufacturing

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