Quality Assurance Leader (ISO & FDA)

SPECTRUM PLASTICS GROUP; Minneapolis (MN); On-site; USD 100,000 - 120,000; Full time

Job summary

Spectrum Plastics Group in Minneapolis, MN is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements across the site. You will lead QA activities, develop inspection procedures, and mentor a team to uphold ISO and FDA standards.

Responsibilities include reading drawings, coordinating audits, liaising with customers, and promoting a robust quality culture. Strong problem solving and communication are essential.

Qualifications

• Must have a degree in Science, Engineering, or Business with 3–5 years of QA in manufacturing.
• Solid understanding of ISO 9001:2015 and ISO 13485:2016 standards.
• Certified Lead Auditor.
• Experience managing third-party and customer audits.
• Strong QA/QC theory, procedures, and PFMEA/Control Plan knowledge.
• Reading engineering drawings and quality specifications.

Responsibilities

• Read and interpret engineering drawings and quality specs to prepare inspection procedures.
• Investigate and resolve quality problems; perform internal QA audits.
• Manage and review customer and third-party audits; liaise with customers on quality issues.
• Lead QA activities and communicate objectives to all employees; train staff.
• Maintain ISO and QMS documents; support root-cause analysis and corrective actions.
• Collaborate with departments to ensure ISO Class 8 cleanroom integrity.

Skills

Quality management

Regulatory compliance

Root-cause analysis

Audit leadership

Communication

Problem solving

Materials/QA knowledge

Education

Bachelor's degree (Preferred)

Tools

Excel

Word

Visio

Access

Outlook

Job description

Spectrum Plastics Group in Minneapolis, MN is seeking a Quality Assurance Manager to ensure regulatory compliance and drive quality improvements across the site. You will lead QA activities, develop inspection procedures, and mentor a team to uphold ISO and FDA standards.

Responsibilities include reading drawings, coordinating audits, liaising with customers, and promoting a robust quality culture. Strong problem solving and communication are essential.