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Spectrum Plastics Group, A DuPont Business · 2 months ago

Quality Systems Manager

Minneapolis, MN

Full-time

Onsite

Senior Level

5+ years exp

Spectrum Plastics Group, a DuPont Business, is seeking a Quality Systems Manager to establish and maintain a configuration management system that meets regulatory and quality requirements. The role involves managing document control functions, ensuring compliance with ISO standards, and promoting a culture of safety within the organization.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

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 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

Qualification

Document managementERP system knowledgeISO complianceMicrosoft OfficeCommunication skillsOrganizational skillsAttention to detail

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

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

Preferred

Background knowledge in an ERP system (preferably IQMS is a plus)

Company

Spectrum Plastics Group, A DuPont Business

Acquired in August 2023 by DuPont, Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices.

Founded in 1961

Alpharetta, Georgia, USA

1001-5000 employees

https://www.spectrumplastics.com/

H1B Sponsorship

Spectrum Plastics Group, A DuPont Business has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)