Spectrum Plastics Group, A DuPont Business
Quality & Regulatory Affairs Manager
Spectrum Plastics Group, A DuPont Business, Tucson, Arizona, United States, 85718
Job Overview
Coordinate the development and administration of the company’s quality assurance (QA) and regulatory affairs (RA) throughout the organization, ensuring compliance with customer, company, and regulatory requirements. Establish QA policies and procedures relating to ISO 13485:2016 and FDA 21 CFR Part 820, and manage a Quality Assurance Program that includes quality control, quality engineering, and product safety to meet customer needs. Maintain the quality system to ensure regulatory compliance for all products produced at Xeridiem. Essential Duties
Serve as site Management Representative and ensure the QMS complies with applicable standards, fostering a quality-focused culture. Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and global regulatory expectations. Direct internal and external audits (FDA, ISO, customer, notified body); manage responses to findings; drive CAPA closure and systemic improvements. Oversee all QMS subsystems including document control, change management, nonconformance handling, training, supplier quality, and product release. Drive continuous improvement initiatives using tools such as FMEA, root cause analysis, SPC, Lean/Six Sigma, and Kaizen to enhance quality and operational performance. Lead efforts to identify and reduce Cost of Poor Quality (COPQ) through proactive risk identification, process standardization, scrap reduction, and preventive action. Implement or enhance quality automation and digital transformation initiatives across QMS functions to increase process efficiency and data visibility. Monitor and report KPIs, quality trends, and management review data to inform leadership decisions. Provide quality oversight for new product development, validations, and design transfer to manufacturing, ensuring integration of quality and regulatory requirements from concept through commercialization. Oversee supplier qualification, performance monitoring, and resolution of supplier-related quality issues through collaboration and audits. Supervise, mentor, and develop a team of quality engineers, inspectors, and specialists, including goal setting, coaching, and performance management. Act as the site’s Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR 2017/745 and internal policy. Provide regulatory strategies and guidance to cross-functional teams throughout the product lifecycle, including design control, labeling, and post-market activities. Prepare, review, and submit domestic and international regulatory submissions (e.g., 510(k), CE Technical Files, renewals, amendments). Maintain and update technical documentation, registrations, and licenses to ensure regulatory compliance for all commercialized products. Interface with regulatory authorities (FDA, Notified Bodies, and other global agencies) to support product submissions, inspection readiness, and response coordination. Monitor and communicate changes in global regulatory requirements, standards, and guidance documents; implement updates to internal procedures and documentation accordingly. Support post-market surveillance activities, including adverse event reporting, complaint trending, and field action documentation. Qualifications
Required: Bachelor’s degree in a scientific or engineering discipline (e.g., biomedical, mechanical, chemical, industrial); equivalent experience considered. Minimum 5–7 years of Quality Assurance leadership in a regulated industry, with experience in Regulatory Affairs. Minimum 2 years of people management or supervisory experience (direct reports, mentoring, team development). Deep understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with global regulatory frameworks and submission processes. Successful track record in audits, inspections, CAPA systems, product quality investigations, and QMS improvements. Experience with electronic QMS (eQMS) platforms and document management systems. Proficient in Microsoft Office and quality/regulatory systems; skilled in data analysis, reporting, and dashboards. Strong communication, leadership, and cross-functional collaboration skills. Commitment to understanding and complying with all SPG and DuPont safety policies and procedures. Preferred: Certifications such as RAC, CQE, CQA, CMQ/OE, or Six Sigma Green/Black Belt. Experience leading continuous improvement, COPQ reduction, and quality automation or digital transformation initiatives. Prior success in global regulatory submissions and product launch support, especially for Class II/III medical devices or combination products. Familiarity with Lean Manufacturing and operational excellence methodologies. Working Conditions
Works under general supervision. Light physical activity with majority of time spent on the manufacturing line where protective clothing is required. Flexible hours and ability to work around chemicals. Additional Information
This job description is not intended to be exhaustive. Other duties and responsibilities may be assigned as needed. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance and Engineering Industries: Medical Equipment Manufacturing and Plastics Manufacturing
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Coordinate the development and administration of the company’s quality assurance (QA) and regulatory affairs (RA) throughout the organization, ensuring compliance with customer, company, and regulatory requirements. Establish QA policies and procedures relating to ISO 13485:2016 and FDA 21 CFR Part 820, and manage a Quality Assurance Program that includes quality control, quality engineering, and product safety to meet customer needs. Maintain the quality system to ensure regulatory compliance for all products produced at Xeridiem. Essential Duties
Serve as site Management Representative and ensure the QMS complies with applicable standards, fostering a quality-focused culture. Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and global regulatory expectations. Direct internal and external audits (FDA, ISO, customer, notified body); manage responses to findings; drive CAPA closure and systemic improvements. Oversee all QMS subsystems including document control, change management, nonconformance handling, training, supplier quality, and product release. Drive continuous improvement initiatives using tools such as FMEA, root cause analysis, SPC, Lean/Six Sigma, and Kaizen to enhance quality and operational performance. Lead efforts to identify and reduce Cost of Poor Quality (COPQ) through proactive risk identification, process standardization, scrap reduction, and preventive action. Implement or enhance quality automation and digital transformation initiatives across QMS functions to increase process efficiency and data visibility. Monitor and report KPIs, quality trends, and management review data to inform leadership decisions. Provide quality oversight for new product development, validations, and design transfer to manufacturing, ensuring integration of quality and regulatory requirements from concept through commercialization. Oversee supplier qualification, performance monitoring, and resolution of supplier-related quality issues through collaboration and audits. Supervise, mentor, and develop a team of quality engineers, inspectors, and specialists, including goal setting, coaching, and performance management. Act as the site’s Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR 2017/745 and internal policy. Provide regulatory strategies and guidance to cross-functional teams throughout the product lifecycle, including design control, labeling, and post-market activities. Prepare, review, and submit domestic and international regulatory submissions (e.g., 510(k), CE Technical Files, renewals, amendments). Maintain and update technical documentation, registrations, and licenses to ensure regulatory compliance for all commercialized products. Interface with regulatory authorities (FDA, Notified Bodies, and other global agencies) to support product submissions, inspection readiness, and response coordination. Monitor and communicate changes in global regulatory requirements, standards, and guidance documents; implement updates to internal procedures and documentation accordingly. Support post-market surveillance activities, including adverse event reporting, complaint trending, and field action documentation. Qualifications
Required: Bachelor’s degree in a scientific or engineering discipline (e.g., biomedical, mechanical, chemical, industrial); equivalent experience considered. Minimum 5–7 years of Quality Assurance leadership in a regulated industry, with experience in Regulatory Affairs. Minimum 2 years of people management or supervisory experience (direct reports, mentoring, team development). Deep understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with global regulatory frameworks and submission processes. Successful track record in audits, inspections, CAPA systems, product quality investigations, and QMS improvements. Experience with electronic QMS (eQMS) platforms and document management systems. Proficient in Microsoft Office and quality/regulatory systems; skilled in data analysis, reporting, and dashboards. Strong communication, leadership, and cross-functional collaboration skills. Commitment to understanding and complying with all SPG and DuPont safety policies and procedures. Preferred: Certifications such as RAC, CQE, CQA, CMQ/OE, or Six Sigma Green/Black Belt. Experience leading continuous improvement, COPQ reduction, and quality automation or digital transformation initiatives. Prior success in global regulatory submissions and product launch support, especially for Class II/III medical devices or combination products. Familiarity with Lean Manufacturing and operational excellence methodologies. Working Conditions
Works under general supervision. Light physical activity with majority of time spent on the manufacturing line where protective clothing is required. Flexible hours and ability to work around chemicals. Additional Information
This job description is not intended to be exhaustive. Other duties and responsibilities may be assigned as needed. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance and Engineering Industries: Medical Equipment Manufacturing and Plastics Manufacturing
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