Quality Assurance Leader - ISO/FDA Compliance

Dupont; Minneapolis (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Spectrum Plastics Group is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements in a manufacturing setting. You will lead QA audits, maintain Quality Systems, and support continuous improvement across departments.

The role requires a science or business degree and 3–5 years in QA, with strong analytical and communication skills and experience with ISO standards.

Qualifications

• Must possess degree of Science or Business, with 3-5 years’ experience in Quality Assurance in a manufacturing environment.
• Thorough understanding of ISO 9001:2015 and ISO 13485:2016 standards.
• Must be a certified Lead Auditor.
• Experience managing third party regulatory and customer audits.
• Strong communication and analytical skills.
• Knowledge of measuring/test equipment and GR&Rs.

Responsibilities

• Responsible for site regulatory compliance.
• Ensure maintenance and implementation of Quality Systems and training.
• Lead audits by Third-Party Registrars/Customers.
• Provide leadership within QA activities and promote a Quality culture.
• Support ISO and QMS system utilization cost-effectively.
• Manage and report key Quality Performance Metrics.

Skills

Regulatory compliance

Auditing

Root cause analysis

Quality systems

Communication skills

Problem solving

Team leadership

Quality metrics

Education

Bachelor's degree in Science or Business

Tools

Word

Excel

Visio

Access

Outlook

Job description

Spectrum Plastics Group is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements in a manufacturing setting. You will lead QA audits, maintain Quality Systems, and support continuous improvement across departments.

The role requires a science or business degree and 3–5 years in QA, with strong analytical and communication skills and experience with ISO standards.