Senior Quality Leader - ISO 13485 & FDA QSR Compliance

Regulatory Jobs; Des Moines (IA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health benefits

401(k) plan

Paid time off

Résumé du poste

Katecho seeks a senior Quality Leader to proactively drive the quality system across production operations. You will supervise the Quality Department, govern ISO 13485 and FDA Title 21 Part 820, and ensure timely, accurate inspections and problem solving.

The role requires a strong background in manufacturing supervision, Lean practices, and regulatory compliance. Collaboration with HR and other departments is essential for continuous improvement and policy enforcement.

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.

Responsabilités

• Lead a team by example in work performance, quality, dependability, and communication.
• Drive continuous improvement of the quality system through monitoring production operations and personnel management.
• Supervise Quality Department personnel including staffing, development, training, and performance reviews.
• Communicate with all departments to pursue continuous quality improvement across Katecho.
• Oversee Quality Department inspection, receiving, and test lab staff on the production floor to ensure timely, accurate inspections.

Connaissances

Leadership

Quality management

Team supervision

Continuous improvement

Regulatory compliance

English communication

Formation

Bachelor’s degree in related field

ASQ Green Belt

Outils

Lean Six Sigma

Description du poste

Katecho seeks a senior Quality Leader to proactively drive the quality system across production operations. You will supervise the Quality Department, govern ISO 13485 and FDA Title 21 Part 820, and ensure timely, accurate inspections and problem solving.

The role requires a strong background in manufacturing supervision, Lean practices, and regulatory compliance. Collaboration with HR and other departments is essential for continuous improvement and policy enforcement.