Quality Systems Manager, ISO 13485 & FDA QSR

All Jobs bv; Des Moines (IA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401(k)

Dental & Vision

Job summary

Katecho, a medical device manufacturer in Des Moines, IA, seeks a Quality Manager to lead the quality system initiatives in collaboration with the head of Quality and production leadership.

You will supervise Quality Department staff on the production floor, ensure ISO 13485 and FDA Title 21 Part 820 compliance, drive continuous improvement, and coordinate with other departments to resolve root causes of quality issues.

Qualifications

• Minimum of five years of manufacturing supervision or management experience.
• Bachelor’s degree in a related field preferred.
• ASQ & Green Belt certifications completed within 1-year of employment preferred.
• Some Lean manufacturing implementation experiences or knowledge preferred.

Responsibilities

• Lead a team by example in performance, quality, dependability, and communication.
• Improve quality system through monitoring production operations and adherence to ISO 13485 and FDA QSR.
• Supervise Quality Department personnel including staffing, training, and discipline.
• Coordinate with departments to determine root causes and solve product quality issues.
• Ensure timely and accurate inspections in line with quality standards.

Skills

Team leadership

Communication

Problem solving

Training

Education

Bachelor’s degree in related field

ASQ Green Belt

Tools

Lean manufacturing

Job description

Katecho, a medical device manufacturer in Des Moines, IA, seeks a Quality Manager to lead the quality system initiatives in collaboration with the head of Quality and production leadership.

You will supervise Quality Department staff on the production floor, ensure ISO 13485 and FDA Title 21 Part 820 compliance, drive continuous improvement, and coordinate with other departments to resolve root causes of quality issues.