Quality Assurance Manager: GMP/ISO 13485 & Lean Six Sigma Lead

Lumicity; Thousand Oaks (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Lumicity is seeking a quality-focused engineer to develop and maintain a QMS compliant with GMP, ISO 13485, and FDA regulations at our Thousand Oaks facility in the United States.

You will lead internal and external audits, inspections, and CAPA activities, drive continuous improvement with Lean and Six Sigma, and collaborate with manufacturing, engineering, regulatory, and supply chain teams to oversee quality documentation, validation, staff training, and overall compliance.

Qualifications

• Experience in manufacturing or industrial engineering with a strong quality focus.
• Knowledge of GMP, ISO 13485, GAMP, and FDA regulations.
• Experience conducting quality audits, CAPAs, and process validations.
• Proficiency in GD&T, Lean, Six Sigma, and quality data analysis.

Responsibilities

• Develop and maintain QMS compliant with GMP, ISO 13485, and FDA regulations.
• Lead internal/external audits, inspections, testing, and CAPA activities.
• Drive continuous improvement using Lean and Six Sigma methodologies.
• Collaborate with manufacturing, engineering, regulatory, and supply chain teams.
• Oversee quality documentation, validation, staff training, and compliance.

Skills

GMP knowledge

ISO 13485 knowledge

GAMP knowledge

FDA regulations

GD&T

Lean

Six Sigma

Quality data analysis

Industrial engineering experience

CQE/CQPA preferred

Education

Bachelor's degree in Engineering or related field

CQE/CQPA certification preferred

Job description

Lumicity is seeking a quality-focused engineer to develop and maintain a QMS compliant with GMP, ISO 13485, and FDA regulations at our Thousand Oaks facility in the United States.

You will lead internal and external audits, inspections, and CAPA activities, drive continuous improvement with Lean and Six Sigma, and collaborate with manufacturing, engineering, regulatory, and supply chain teams to oversee quality documentation, validation, staff training, and overall compliance.