Quality Systems Manager

About the Role

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.

Responsibilities

• 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 Database, providing the training documents required for ISO compliance and ensuring timely employee training.
• Create and maintain Bills of Materials, ensuring accuracy and consistency throughout all SPG MN Operations.
• Promote a safe work environment and 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, ensuring full compliance with regulations.
• Provide guidance and advice on methods, procedures, standardization, and requirements.
• Control document new and change control through the ECO ERP system, regulating the change process so only approved and validated changes are incorporated into released product documentation.
• Collaborate with departments to ensure timely implementation of change requests.
• Ensure 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) 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 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 results to Engineering to determine their impact.
• Participate in engineering project kickoff meetings.
• Reconcile month-end tooling sales for accuracy and approval to close projects.
• 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.

Qualifications

• A minimum of 5 years of work experience in a document management role.
• Working knowledge of document control processes.
• Proficient in Microsoft Office applications (Word, Excel, etc.).
• Background knowledge in an ERP system (preferably IQMS is a plus).
• Excellent written and oral communication skills and a strong attention to detail.
• Strong organizational skills.

Skills

• 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.