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Quality Systems Engineer

Spectrum Plastics Group at a glance

SEC filings mentioning "Spectrum Plastics Group": 88search EDGAR

Spectrum Plastics Group

Spectrum Plastics Group is hiring a Quality Systems Engineer in Pleasant Prairie, Kenosha County, to lead quality and regulatory compliance initiatives for our manufacturing operations. This full-time position offers an opportunity to shape how we maintain world-class standards across our organization.

About the Role

As a Quality Systems Engineer, you'll oversee the architecture, documentation, and continuous operation of our Quality Management System to meet FSSC 22000, ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements. Your work ensures that both internal processes and external compliance measures deliver real value to our customers and stakeholders.

What You'll Do

  • Design, document, and refine QMS procedures and work instructions to support regulatory and customer requirements
  • Lead and participate in internal audits and coordinate external audit readiness across all facilities
  • Manage the complete document control workflow to ensure accuracy, accessibility, and version control
  • Investigate quality issues, develop corrective and preventive actions (CAPA), and track effectiveness
  • Drive continuous improvement projects that strengthen product quality and operational efficiency
  • Collaborate with manufacturing, engineering, and management teams on compliance and quality initiatives

What We're Looking For

  • Proven experience implementing or managing Quality Management Systems under ISO 9001, ISO 13485, FSSC 22000, or FDA medical device regulations
  • Strong understanding of regulatory requirements and audit processes
  • Excellent documentation, organizational, and communication skills
  • Ability to analyze problems, develop solutions, and drive sustained improvement
  • Detail-oriented mindset with accountability for compliance and accuracy

About Spectrum Plastics Group

Spectrum Plastics Group is a precision plastic manufacturing company serving the medical device and food-related industries with products engineered to meet rigorous safety and quality standards.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.

To apply for this job please visit www.adzuna.com.

Working in Pleasant Prairie, Kenosha County

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Wisconsin is a state in the Upper Midwest and Great Lakes regions of the United States. It borders Minnesota to the west, Iowa to the southwest, Illinois to the south, Lake Michigan to the east, Michigan to the northeast, and Lake Superior to the north. With a population of about 6 million, and an area of about 65,500 square miles (170,000 km2), Wisconsin is the 21st-largest state by population an

  • Elevation 210m (689 ft)

Source: Wikipedia (state)

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