Director, Global Quality Systems & Compliance

Masimo; Irvine (CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401(k)

Paid Maternity Leave

Wellness Clinic

Job summary

Masimo is seeking a Director of Quality Systems in Irvine, California, responsible for leading the company's Quality Systems strategy and ensuring compliance with regulatory standards. This role will have oversight of key quality functions such as Health Hazard Evaluations and nonconformance management.

The qualified candidate will possess over 10 years in Quality Assurance with strong leadership experience and knowledge of FDA regulations. The position offers a competitive salary and comprehensive benefits package including medical and wellness programs.

Qualifications

• 10+ years of experience in Quality Assurance or Compliance.
• 5+ years of leadership managing teams.
• Strong knowledge of FDA and ISO standards.
• Experience in CAPA, change control processes.

Responsibilities

• Lead and oversee Quality Systems activities.
• Drive continuous improvement initiatives.
• Monitor quality performance through data analysis.
• Support internal and external audits.

Skills

Leadership

Quality Management Systems (QMS)

Regulatory Compliance

Data Analysis

Project Leadership

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s degree in Engineering or related field

Job description

Masimo is seeking a Director of Quality Systems in Irvine, California, responsible for leading the company's Quality Systems strategy and ensuring compliance with regulatory standards. This role will have oversight of key quality functions such as Health Hazard Evaluations and nonconformance management.

The qualified candidate will possess over 10 years in Quality Assurance with strong leadership experience and knowledge of FDA regulations. The position offers a competitive salary and comprehensive benefits package including medical and wellness programs.