Quality Systems Engineer

Spectrum Plastics Group•Pleasant Prairie, WI

About The Position

The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company’s goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness. Act as a role model and ensure safety is built into our QMS and work processes. Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps. Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance. Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality. Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness. Apply problem-solving methodologies to prioritize and resolve quality issues promptly. Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality. Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance. Provide training to employees on quality system requirements to ensure compliance and consistency across departments. Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS. Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready. Drive quality system enhancements, identifying and implementing improvement opportunities across the organization. Other duties as required.

Requirements

A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field.
3-5 years of experience in quality system management within a medical device or other regulated environment.
Strong knowledge of FSSC 22000, ISO 9001, ISO 13485, 21 CFR Part 820, and industry best practices for QMS.
Proficient in CAPA processes, risk management strategies, and both internal and external audit processes.
Demonstrated ability to use QMS software and document control systems to manage regulatory documentation.
Excellent problem-solving, analytical, and troubleshooting skills.
Strong verbal and written communication abilities, capable of interacting with all levels of the organization.
Experience with Six Sigma or other process improvement methodologies to drive quality enhancements.
Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.

Responsibilities

Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.
Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.
Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.
Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.
Apply problem-solving methodologies to prioritize and resolve quality issues promptly.
Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.
Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.
Provide training to employees on quality system requirements to ensure compliance and consistency across departments.
Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.
Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.
Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.
Other duties as required.